Alcohol wipes from china safe

Alcohol wipes from china safe DEFAULT

[9/01/2017] The U.S. Food and Drug Administration is alerting health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. These products are distributed by Total Resources International, Walnut, California, and Simple Diagnostics Inc., Williston Park, New York.

Products distributed by Total Resources:

  • Alcohol Prep Pad, single count, NDC 54429-0101-1
  • Antiseptic Towelettes, Benzalkonium Chloride / First Aid Antiseptic, single count

Products distributed by Simple Diagnostics:

  • Alcohol Prep Pads, 100 individual pads per package, NDC 98302-0001-05
  • Alcohol Pad, 70% Isopropyl Alcohol, Sterile

Alcohol pads and antiseptic towelettes are used by health care professionals and patients for preparation of the skin prior to injection, as well as in first aid to decrease germs in minor cuts, scrapes and burns. The use of these alcohol pads and antiseptic towelettes could cause infections.

Patients, health care facilities and pharmacies that have alcohol pads and antiseptic towelettes labeled by Total Resource or Simple Diagnostics should immediately stop using them and discard the products. Patients should contact a doctor if they experienced any adverse reactions after using these products.

FDA initially contacted Foshan on May 25, 2017, regarding a recall, and had several follow-up meetings with the company. However, Foshan has not taken action to remove its alcohol pads or antiseptic towelettes from the market.

FDA placed all drug products made by Foshan on import alert on May 23, 2107, to stop these products from entering the United States. However, FDA is concerned these products might still be in U.S. distribution. FDA also sent Foshan a warning letter on August 1, 2017, for violations of current good manufacturing practice regulations.

To date, FDA has not received any adverse event reports related to the use of these alcohol pads or antiseptic towelettes. FDA asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch program:

FDA is aware of the following products. However, there may be additional products on the market.

Foshan 1

Foshan 2

Foshan 3

Foshan 4

  • Content current as of:

Sours: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-not-use-alcohol-pads-or-benzalkonium-chloride

Antiseptic wipes made in China pulled in U.S.

Chinese-made antiseptic wipes and swabs distributed in the U.S. by a New York medical supply company have been recalled because of potential microbial contamination.

DUKAL Corp. of Ronkonkoma, N.Y., issued a nationwide voluntary recall of 4,300 cases of benzalkonium chloride swabs and antiseptic wipes, saying they may contain Burkholderia cepacia, bacteria that can cause infection and illness in people with underlying health problems. The recall was issued on July 25, but posted by the U.S. Food and Drug Administration on Wednesday.

“All customers are advised to discontinue use of products identified in this recall immediately as their use could lead to infections, some of which pose certain health risks in immune-suppressed patients,” the company said in a statement.

Two of some 50 lots of products, including Zee antiseptic swabs and Dukal BZK swabs, were found to contain the bacteria, John Grasso, vice president of operations for DUKAL, told NBCNews.com. 

“We’ve actually recalled the product back to 2009,” Grasso said.

The swabs were manufactured by Jianerkang Medical Dressing Co. The company’s website indicates it’s located in Jintan City in Jiangsu Province, China. 

For information about specific brands and packages, click here.

Grasso said FDA officials detected the contamination during a routine port inspection of imported products. The problem was traced to a faulty machine at the Chinese plant, he added. It has since been resolved.

DUKAL makes a wide range of medical products including antiseptics and cleansers, bandages, tapes and gauze dressings. Many of those products are included in first-aid kits and medical kits sent to people with medical problems. They are sold both over-the-counter and as part of kits. 

No illnesses have been associated with the potentially tainted products, Grasso said.

“For average healthy people, the presence of Burkholderia cepacia is not likely to cause serious health risks,” the company said.

FDA officials could not immediately comment on results of inspections or other enforcement actions at the Chinese plant.

Echoes of past tainted wipe recalls

The recall of antiseptic wipes comes more than a year after a massive recall of swabs, wipes and other products made and distributed by sister Wisconsin firms highlighted serious health risks and regulatory failures regarding microbial contamination in medical supplies.

As of June, FDA officials said H&P Industries Inc. and the Triad Group of Hartland, Wis., remained closed under the terms of a federal consent decree that prohibits the firms from making or distributing products.

The firms have been cited in nearly a dozen lawsuits nationwide that alleged that contaminated wipes or other products led to serious illnesses and death.

The family of a 2-year-old Houston boy, Harrison Kothari, alleged that he died after contracting an infection caused by Bacillus cereus, the bacterium detected in the H&P wipes. The boy’s parents, Sandra and Shanoop Kothari, settled their lawsuit with H&P Industries in April, according to court records and interviews.

Other wipe-makers have recalled products because of potential contamination as well. Last September, Professional Disposables Inc. of Orangeburg, N.Y., recalled all lots of five different kinds of non-sterile alcohol prep pads because of possible contamination with Bacillus cereus.

And in April 2011, Rockline Industries of Springdale, Ark., recalled nearly a million units of baby wipes, including brands sent to Winn-Dixie stories and Walmart, because of potential contamination with Enterobacter gergoviae.

In February 2011, as scrutiny of the Triad alcohol prep pad recall was heating up, the DUKAL Corp. issued a press release from its Shanghai office. 

"Dukal's alcohol wipes are manufactured in accordance with all applicable FDA guidelines and strictly controlled and monitored by Dukal's quality assurance department," the release said. 

Related stories on Vitals: 

JoNel Aleccia and JoNel Aleccia

Sours: https://www.nbcnews.com/health/health-news/antiseptic-wipes-made-china-pulled-u-s-flna918757
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Recall of certain hand sanitizers that may pose health risks (Part 1 - June 17, 2020 to March 24, 2021)

Product Reason for recall Recalling company NPN or DIN Affected lot number(s) Expiry date Date added 204 Hand Sanitizer Not authorized for sale in Canada; product not authorized to contain technical-grade ethanol; some lots contain technical-grade ethanol; missing risk statements 204 Spirits Inc. None All All 2020-08-20 Adclean (Technical) Contains unacceptable ingredient, ethyl acetate Adfast Canada Inc. 80098241 200423-114854 April 2022 2020-07-10 Adclean (Technical) Contains unacceptable ingredient, ethyl acetate Adfast Canada Inc. 80098241 200505-114929 May 2022 2020-07-10 Agape Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Formula A Inc. 80099669 (does not appear on the label) 080620 June 2022 2020-07-17 Aktif Antiseptique instantané pour les mains Contains unacceptable ingredient, ethyl acetate Laboratoire Hygienex Inc. 80098088 189665189574 May 2022 2020-06-10 Alco-Klean / Magiechem Inc. - Assainisseur À Base D'Éthanol 80%V/V Missing risk statements; product not authorized to contain technical-grade ethanol Magiechem Inc. 80099007 16679-200421 Not printed on the label 2020-07-17 Alcohol Hand Rub Missing risk statements; product not authorized to contain technical-grade ethanol After Dark Distillery Ltd. 80098216 Batch #3 April 2022 2020-09-28 Alcohol Hand Rub Missing risk statements; product not authorized to contain technical-grade ethanol After Dark Distillery Ltd. 80098216 Batch #4 May 2022 2020-09-28 Alcohol Hand Rub Missing risk statements; product not authorized to contain technical-grade ethanol After Dark Distillery Ltd. 80098216 Batch #5 June 2022 2020-09-28 Annex/Raft Hand Sanitizer Faulty packaging; not properly labelled Annex Ale Project, Limited 80098532 001
002
003
004
005
006
007
008
009
010
011 April 25, 2020 to June 9, 2020 2021-02-03Anti-Microbe Not properly labelled (improper directions for use in children) ATOMS F.D., INC. 02248351 All All 2021-02-03 Ascencia Désinfectant pour les mains Incorrect NPN; product not authorized to contain technical-grade ethanol; missing risk statements Arclay Natural Technologies

80098625 appears on the label, which is the wrong NPN.

80100505 is the correct NPN.

EN142 May 2022 2020-07-06 Avery Essentials Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Universal Consumer Brands 80099591 20E31A May 2023 2020-06-24 Avery Essentials Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Universal Consumer Brands 80099412 20C30A
20D19A April 2023 2020-06-24 Avery Essentials Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Universal Consumer Brands 80099412 20E08A
20E01A May 2023 2020-06-24 Bath Springs Missing risk statements; product not authorized to contain technical-grade ethanol South Ridge Packing Co. Ltd. 80099105 20200418
20200421
20200422
20200423
20200424
20200427
20200428
20200429
20200430 April 2022 2020-09-14 Bath Springs Missing risk statements; product not authorized to contain technical-grade ethanol South Ridge Packing Co. Ltd. 80099105 20200501
20200504
20200505
20200507
20200513
20200514 May 2022 2020-09-14 Bath Springs Missing risk statements; product not authorized to contain technical-grade ethanol South Ridge Packing Co. Ltd. 80099105 20200602
20200608 June 2022 2020-09-14 Biogel; Préférence May contain unacceptable ingredient, methanol or ethyl acetate Groupe Savon Olympics, Inc. 80098684 All lots beginning with 0C, 0D9, 0E9, and 0F9 April 2022. Expiry date not printed on all labels. 2021-03-24 Biogel Contains unacceptable ingredient, methanol Groupe Savon Olympic Inc. 80098684 0E971
0E973 Not printed on the label 2021-03-15 Biogel Contains unacceptable ingredient, ethyl acetate Groupe Savon Olympics, Inc. 80098684 0D991
0D992
0D963
0D964
0E998
0E997
0E994 April 2022 2020-07-03Bio Life Hand Sanitizer Contains unacceptable ingredient, methanol; ethanol content is less than required amount to be effective 10932540 Canada Inc./ Bio Life Sciences Corp. 80101522 All All 2020-11-13 BioOrigin Pure Hands Antibacterial Hand Gel Missing risk statements; product not authorized to contain technical-grade ethanol Mineral Origin Inc. 80098887 12020
12720-2
14020
14320 October 2021
November 2021
November 2021
November 2021 2020-07-30 BioOrigin Pure Hands Antibacterial Hand Gel Missing risk statements; product not authorized to contain technical-grade ethanol Mineral Origin Inc. None 09920
10020
10520
10620
11120
11220
12020
12720
13320
14020
14620 Not printed on the label 2020-07-30 Biovectra Sanitizer Contains unacceptable ingredient, ethyl acetate BioVectra, Inc. 80097796 53473 September 2020 2020-07-21 Biovectra Sanitizer Contains unacceptable ingredient, ethyl acetate BioVectra, Inc. 80097796 53999 December 2020 2020-07-21 Biovectra Hand Sanitizer - Topical Gel Contains unacceptable ingredient, ethyl acetate BioVectra, Inc. 80099246 53491
53509
53518
53583 April 2021 2020-07-21 Biovectra Hand Sanitizer - Topical Gel Contains unacceptable ingredient, ethyl acetate BioVectra, Inc. 80099246 53815
53875
53833 May 2021 2020-07-21 Biovectra Hand Sanitizer - Topical Gel Contains unacceptable ingredient, ethyl acetate BioVectra, Inc. 80099246 53948 June 2021 2020-07-21 Birds & Bees Distillery 70% Ethyl Alcohol Missing risk statements; product not authorized to contain technical-grade ethanol Birds & Bees Winery Inc. 80098632 All. Lot number not printed on all labels. April 2023 2020-10-19 Blindman Brewing Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Blindman Brewing Inc. 80098092 S-20200426
S-20200427
S-20200427-2
S-20200428 September 2020 2020-09-14 Blindman Brewing Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Blindman Brewing Inc. 80098092 S-20200501-1
S-20200501-2
S-20200504
S-20200515
S-20200530 October 2020 2020-09-14 Blindman Brewing Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Blindman Brewing Inc. 80098092 S-20200606 November 2020 2020-09-14 Blindman Brewing Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Blindman Brewing Inc. 80098092 S-20200812 January 2021 2020-09-14 Clean & Green Hand Sanitizer Gel Contains unacceptable ingredient, methanol Hope, Grace and Healing, DBA HgH Integrative Aromatics 80100887 00158 May 2022 2020-08-04 Clean & Green Hand Sanitizer Gel Contains unacceptable ingredient, methanol Hope, Grace and Healing, DBA HgH Integrative Aromatics 80100887 00161 June 2022 2020-08-04 Clean Freak Missing risk statements; product not authorized to contain technical-grade ethanol Tri Natural Mfg. 80099541 HS2006
HS2007
HS2012
HS2013 May 2021 2020-09-14 Clean Freak Missing risk statements; product not authorized to contain technical-grade ethanol Tri Natural Mfg. 80099541 HS2014
HS2015 June 2021 2020-09-14 Clean Freak Missing risk statements; product not authorized to contain technical-grade ethanol Tri Natural Mfg. 80099541 HS2016
HS2017
HS2018 July 2021 2020-09-14 Concept Manufacturing Ltd - Ethanol Sanitizer 75%; Sani-Soft Sanitizing Skin Cleanser Missing risk statements; product not authorized to contain technical-grade ethanol Concept Manufacturing Ltd. 80099097 All. Not printed on the label. April 1, 2022 to June 4, 2022 2020-11-27Daily Shield Hand Sanitizer Contains unacceptable ingredient, methanol; ethanol content is less than the recommended amount to be effective 10932540 Canada Inc./ Bio Life Sciences Corp. 80098979 All All 2020-11-02 Dash Vapes Hand Sanitizer Contains unacceptable ingredient, ethyl acetate DashVapes Inc. Unlicensed (no NPN or DIN on label) 1258969 April 10, 2021 2020-06-11 Defend Gel Hand Sanitizer Contains unacceptable ingredient, ethyl acetate Corporate Facility Supply, Inc. 80100149 20132
20136
20140 May 2022 2020-07-21 Dermogen Contains unacceptable ingredient, ethyl acetate Inter Cosmetiques Inc. 80098142 J20HG001
J20HG002
J20HG003
J20HG004
J20HG005
J20HG006
J20HG007
J20HG008
J20HG009
J20HG010
J20HG011
J20HG012
J20HG013
J20HG014 May 2022 2020-07-27 Désinfectant Mousseux Pour les Mains Contains unacceptable ingredient, ethyl acetate Solutions Enviro-Formula, Inc. 80101041 PFFM02200610
PFFM01200610
PFFM03200610
PFFM01200608
PFFM02200605 Not printed on the label 2020-07-21 Eltraderm Hand Sanitizer-70% Ethyl Alcohol Contains unacceptable ingredient, ethyl acetate Eltraderm Limited 80098540 0217 April 2022 2020-06-06 eSafe Contains unacceptable ingredient, methanol Groupe Enov, Inc. Unlicensed (no NPN or DIN on label) 20-115
20-120
20-121 April 2021 2020-07-03 eSafe Contains unacceptable ingredient, methanol Groupe Enov, Inc. Unlicensed (no NPN or DIN on label) 20-125
20-126
20-181 May 2021 2020-07-03 Facility Plus Complete Facility Services-Hand Sanitizer 70% Alcohol Contains unacceptable ingredient, ethyl acetate The A&J Power Group Inc., DBA Facility Plus Unlicensed (no NPN or DIN on label) 07222 May 2022 2020-07-21 Farmessentials Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Tri Natural Mfg. 80099541 HS2008
HS2009 May 2021 2020-09-14 Farmessentials Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Tri Natural Mfg. 80099541 HS2010 June 2021 2020-09-14 Frid + Russell Hand Sanitizer Contains unacceptable ingredient, ethyl acetate Green Dolphin Systems Corp. Unlicensed (no NPN or DIN on label) All. Lot number not printed on the label. Not printed on the label. 2020-07-10 Gel 700 Hand Sanitizer Contains unacceptable ingredient, ethyl acetate Nature's Own Cosmetic Company Inc. 80100166 118 mL format
L00521024
L00521025
L00525006 236 mL format
L00527003
L00528001
L00530003
L00525016
L00526003
L00526011
L00527001
L00528011
L00530002
L00531002 3785 mL format
L00515003 May 2022 2020-06-09 Gel 700 Hand Sanitizer Contains unacceptable ingredient, ethyl acetate Nature's Own Cosmetics Company 80100166 L00420003
L00425001
L00427007
L00501001 April 2022 2020-06-17 Gel 700 Hand Sanitizer Contains unacceptable ingredient, ethyl acetate Nature's Own Cosmetics Company 80100166 L00512004 May 2022 2020-06-17 Gel Antiseptique Pour Les Mains Contains unacceptable ingredient, ethyl acetate Mégalab Inc. 80015567 5135
5137
5138
5139
5142
5144
5149
5151
5152
5160 March 2022 2020-06-22 Gel désinfectant pour les mains Contains unacceptable ingredient, ethyl acetate Solutions Enviro-Formula, Inc. 80100221 PFGA20052201
PFGA1200512
PFFG01200604
PFFG01200529
PFFG02200525
PFFG04200527 Not printed on the label 2020-07-21 Gentle Hand Sanitizer With Aloe Contains unacceptable ingredient, ethyl acetate Angel Cosmoceuticals, Inc. 80098753 N753-01
N753-02
N753-03
N753-04
N753-05
N753-06 May 2022 2020-07-21 Germ Eliminator Contains unacceptable ingredient, methanol 677042 Ontario Ltd. (DBA Donview Manufacturing) 80101737 150301 December 2020 2020-07-10 Germ Eliminator Contains unacceptable ingredient, methanol 677042 Ontario Ltd. (DBA Donview Manufacturing) 80101737 150302 December 2020 2020-07-10 Germ Eliminator Contains unacceptable ingredient, ethyl acetate 677042 Ontario Ltd. (DBA Donview Manufacturing) 80101737 150304 December 2023 2020-07-10 Germs Be Gone Hand Sanitizer Gel Not properly labelled (incorrect label) Brands International Corporation 80101519 20146030 May 2023 2021-02-03 Germzero Contains unacceptable ingredient, ethyl acetate Flash Beauté Inc. 80099604 243601 November 2022 2020-06-22 Gigi's Goodbye Germs Hand Sanitizer Not authorized for sale in Canada Simply at Home, Inc. Unlicensed. Affected lots are labelled with the incorrect NPN 00167630 or 80099956 BB/MA 30/AL/2025
BB/MA 29/AL/2025
BB/MA 28/AL/2025
BB/MA 27/AL/2025
BB/MA 24/AL/2025
BB/MA 23/AL/2025
BB/MA 22/AL/2025
BB/MA 21/AL/2025
BB/MA 20/AL/2025
BB/MA 16/AL/2025
BB/MA 15/AL/2025
BB/MA 14/AL/2025 April 2025 2021-02-03 Gigi's Goodbye Germs Hand Sanitizer Not authorized for sale in Canada Simply at Home, Inc. Unlicensed. Affected lots are labelled with the incorrect NPN 00167630 or 80099956. BB/MA 07/MA/2025
BB/MA 06/MA/2025
BB/MA 05/MA/2025
BB/MA 04/MA/2025
BB/MA 01/MA/2025 May 2025 2021-02-03 Hand Sanitizer Contains unacceptable ingredient, ethyl acetate Contract Packaging Distributions Inc. 80098453 8613026
8613042
8613048
8613055
8613057
8613058
8613061
8613064
8613066 April 2022 2020-06-06 Hand Sanitizer Contains unacceptable ingredient, ethyl acetate JIS Enterprises Inc. (DBA JIS Specialty Products) 80099670 11042020
16042020
21042020
23042020 April 2022 2020-07-27 Hand Sanitizer Alco-San Contains unacceptable ingredient, ethyl acetate Crown Chemical Products, Inc. Unlicensed (no NPN or DIN on label) 03130
03310
04070
51420-20 Not printed on the label 2020-06-30 Hand Sanitizer Alco-San Contains unacceptable ingredient, ethyl acetate Crown Chemical Products, Inc. Unlicensed (no NPN or DIN on label) 51420-21
51520-20 Not printed on the label 2020-07-03 Hand Sanitizer
Désinfectant pour les mains Contains unacceptable ingredient, ethyl acetate Walker Emulsions Ltd. 80100040 210061 Not printed on the label 2020-06-06 Hand Sanitizer Mano-San Contains unacceptable ingredient, ethyl acetate Shifaah Health 80100572 04070 April 2022 2020-07-21Hangel Advanced Formula Not authorized for sale in Canada; ethanol content is less than required to be effective Hangel Canada Inc. Unlicensed (no NPN or DIN on the label) All All 2021-02-17Hangel Advanced Formula spray Not authorized for sale in Canada Hangel Canada Inc. Unlicensed (no NPN or DIN on the label) All All 2021-02-17Hangel Antibacterial Hand Wipes Not authorized for sale in Canada; ethanol content is less than required to be effective Hangel Canada Inc. Unlicensed (no NPN or DIN on the label) All All 2021-02-17Hangel New Advanced Formula Not authorized for sale in Canada Hangel Canada Inc. Unlicensed (no NPN or DIN on the label) All All 2021-02-17 Happy Natural Products - Ethanol Sanitizer 80% (May also be sold as Happy Hand Sanitizer) Not properly labelled (Missing NPN, lot number and expiry date) Midori Products, Inc. 80099774 Not printed on the label Not printed on the label 2021-02-03 Healthcare Plus Sanitizing Hand Gel Contains unacceptable ingredient, ethyl acetate The Color Group, Division of Canadian Custom Packaging 80002430 024002
024012
024022
021032
024042
024072
024082
024092
024003 April 2022 2020-06-30 Hello Bello Hand Sanitizer Gel Alternate Brand Names: SiL Hand Gel Sanitizer; AK Hand Sanitizer; Carry Clean Hand Gel; Defcon Hand Sanitizer; Lifebrand Hand Sanitizer; SiL Antiseptic Gel Not properly labelled (improper directions for use in children); sold without proper testing Unconditional Love Canada, Inc. 80100271 All All 2021-02-03 Hello Bello Hand Sanitizer Spray Alternate Brand Names: Hand Sanitizer Spray Not properly labelled (improper directions for use in children); sold without proper testing Unconditional Love Canada, Inc. 80096879 All All 2021-02-03 Hello Bello Hand Sanitizer Spray Alternate Brand Names: SiO2 Innovation Labs Hand Sanitizer Spray; Carry Clean Hand Sanitizer Spray; DEFCON 1 Hand Sanitizer Spray; McCaughey Consumer Products Hand Sanitizer Spray Not properly labelled (improper directions for use in children); sold without proper testing Unconditional Love Canada, Inc. 80099139 All All 2021-02-03 Helping Hands Ethanol Sanitizer 72% Missing risk statements; product not authorized to contain technical-grade ethanol Porter's Tonic Inc. 80099170 10001
10002 May 2022 2020-09-28 Helping Hands Ethanol Sanitizer 72% Missing risk statements; product not authorized to contain technical-grade ethanol Porter's Tonic Inc. 80099170 10003 June 2022 2020-09-28 HeyPur Contains unacceptable medicinal ingredient, 1-propanol Heyseller, Inc. 80099351 All. Not printed on the label. Not printed on the label 2020-12-11 Holistic Living 70% Alcohol Disinfectant Antiseptic Not authorized for sale in Canada; Missing risk statements; product not authorized to contain technical-grade ethanol Lusty Libation, Inc. None ISO007 May 2023 2020-09-04 HydraPure Gel Missing risk statements; product not authorized to contain technical-grade ethanol Les Eaux Saint-Leger/ Waters, Inc. 80097923 20119 April 2021 2021-02-03 HydraPure Gel Missing risk statements; product not authorized to contain technical-grade ethanol Les Eaux Saint-Leger/ Waters, Inc. 80097923 20128 May 2021 2021-02-03 Isogel Contains unacceptable ingredient, ethyl acetate Lalema Inc. 80098996 5900 0004 May 13, 2021 2020-06-11 Keep Calm - Assainisseur à base d'éthanol 70% Contains unacceptable ingredient, ethyl acetate Station-22 80098731 L200416-005
L200415-007
L200410-008 April 2022 2021-03-15 Keep Calm - Assainisseur à base d'éthanol 70% Contains unacceptable ingredient, ethyl acetate Station-22 80098731 L200504-005 May 2022 2021-03-15 Kleen RX Hand Sanitizer Gel Contains unacceptable ingredient, ethyl acetate Spa Dent, Inc. 80098426 2010810 April 2023 2020-07-21 KS-Progel Plus Contains unacceptable ingredient, ethyl acetate Delta Pharma Inc. 80097773 200417 April 2022 2020-07-27 Last Best Brewing and Distilling Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Last Best Brewing and Distilling, Inc. 80099050 001 May 2021 2020-10-13 Manogel Contains unacceptable ingredient, methanol Constant America 80098846 04291
04292
04293
04295
04301
04321 March 2022 2020-07-03 Manogel Contains unacceptable ingredient, ethyl acetate Constant America 80098846 04351 April 2022 2020-07-21 MB Hand Sanitizer Contains unacceptable ingredient, ethyl acetate Multi-Blend Ltd. 80099571 May 5, 2020
May 6, 2020
May 11, 2020
May 12, 2020
May 14, 2020
May 19, 2020
May 28, 2020 May 2022 2020-07-21 MB Hand Sanitizer Contains unacceptable ingredient, ethyl acetate Multi-Blend Ltd. 80099571 June 3, 2020
June 16, 2020 June 2022 2020-07-21 Med Clean Hand Sanitizer Incorrect NPN; product not authorized to contain technical-grade ethanol; missing risk statements Brands International Corporation 80021511 20100001 April 9, 2023 2020-06-24 Nomad Hand Sanitizer (Lemongrass) Missing risk statements; product not authorized to contain technical-grade ethanol Rocky Mountain Soap Company 80097907 04092001 to 04172003
04232003 to 04252007
04262001 to 04282005
04302001 April 2021 2020-10-13 Nomad Hand Sanitizer (Lemongrass) Missing risk statements; product not authorized to contain technical-grade ethanol Rocky Mountain Soap Company 80097907 05032001 to 05082004
05122001 to 05232006 May 2021 2020-10-13 Nomad Hand Sanitizer (Lemongrass) Missing risk statements; product not authorized to contain technical-grade ethanol Rocky Mountain Soap Company 80097907 06022001 to 06082001 June 2021 2020-10-13 Noteworthy Handrub Missing risk statements; product not authorized to contain technical-grade ethanol The Dubh Glas Distillery Inc. 80098926 20200417
20200529 Not printed on the label 2020-09-14 Opti-Max Opti-Pure Product not authorized to contain technical-grade ethanol; missing risk statements Les Produits Optimax Inc. 80099476 20200515 May 2022 2020-07-30 Prairie Potions Purify Hand Sanitizer and Antibacterial Spray Contains unacceptable ingredient, methanol Prairie Potions Unlicensed (no NPN or DIN on label) All. Not printed on the label. Not printed on the label 2020-10-13 Protectenol Hand Sanitizer Liquid Contains unacceptable ingredient, ethyl acetate Applied Lubrication Technology 80098373 20-070
20-083
20-366
20-367
20-368
20-369
20-370
20-371
20-372
20-373 Not printed on the label 2020-06-10 Protectenol Hand Sanitizer Missing risk statements Applied Lubrication Technology Inc. 80098373 20-0110
20-0111
20-0112
20-0113
20-0114
20-0115
20-0116
20-0117 Not printed on the label 2020-07-06 Protectenol Hand Sanitizer Missing risk statements Applied Lubrication Technology Inc. 80098373 20-075 to 20-082
20-084 to 20-100 
20-103 to 20-144 
20-148 to 20-209 
20-211 to 20-295 
20-298 to 20-306 
20-310 to 20-312 
20-314 to 20-330 
20-338 to 20-363 
20-397
20-405
20-419
20-421
20-422
20-426
20-427 Not printed on the label 2020-06-24Protegel Not authorized for sale in Canada Protegel Quebec Inc. Unlicensed (no NPN or DIN on the label) All All 2021-02-17Protegel (75% éthanol) Not authorized for sale in Canada Protegel Quebec Inc. Unlicensed (no NPN or DIN on the label) All All 2021-02-17Protegel Antibactérien en forme de gel (75-82% éthanol) Not authorized for sale in Canada; incorrect NPN Protegel Quebec Inc. Unlicensed (no NPN or DIN on the label) All All 2021-02-17Protegel formule avancée Not authorized for sale in Canada Protegel Quebec Inc. Unlicensed (no NPN or DIN on the label) All All 2021-02-17Protegel Hand sanitizer Not authorized for sale in Canada Protegel Quebec Inc. Unlicensed (no NPN or DIN on the label) All All 2021-02-17Protegel Nouvelle Formule Antibactérien Not authorized for sale in Canada Protegel Quebec Inc. Unlicensed (no NPN or DIN on the label) All All 2021-02-17 Pure Essentials Lavender and Sage Hand Spray with Denatured Ethanol Not authorized for sale in Canada; contains unacceptable ingredient, methanol Pure Essentials Inc. Unlicensed (no NPN or DIN on the label) All Not printed on the label 2020-10-19 Pure Essentials Orange and Niaouli Hand Spray with Denatured Ethanol Not authorized for sale in Canada; contains unacceptable ingredient, methanol Pure Essentials Inc. Unlicensed (no NPN or DIN on the label) All Not printed on the label 2020-10-19 PurGerme (4 L format) Contains unacceptable medicinal ingredient, 1-propanol Groupe LAV Inc. 80098625 80098255 July 2023 2020-11-27 PurGerme (4 L format) Contains unacceptable medicinal ingredient, 1-propanol Groupe LAV Inc. 80098625 80098625-06 September 2023 2020-11-27 PurGerme; ByeByeGerms; Cardea Contains unacceptable medicinal ingredient, 1-propanol Groupe LAV Inc. 80098625 All lots manufactured between March 2020 and September 2020 except
SO-0629A, SO-0629B,
80098625,
80098625-8,
2010002,
2010006,
2010007,
2010008,
2010013,
2010014,
2010015,
2011001,
2011002,
2011004,
2011005,
2011006,
2012001, and
2012002 March 2023 to September 2023 2021-02-03 Purus Contains unacceptable ingredient, methanol Pharmalab, Inc. 80097823 B010454
B010486
B010534
B010535
B010591
B010592
B010593
B010594
B010595
B010596
B010915
B010975
B010981 April 2022 2020-07-21 Sanatouch Contains unacceptable ingredient, ethyl acetate Bio Organic Solutions Corp. 80098484 200409-1 April 2022 2020-07-27 Sanify Hand Sanitizer Product not authorized to contain technical-grade ethanol; missing risk statements Lusty Libation, Inc. 80099248 LotSan005
LotSan006
LotSan007
LotSan008 April 2023- June 2023 2020-07-06 Sanilabs Hand Sanitizer 70% Ethanol Contains unacceptable ingredient, ethyl acetate Sanilabs Inc. 80098769 6069 April 20, 2022 2020-06-06 Sanilabs Hand Sanitizer 70% Ethanol Contains unacceptable ingredient, ethyl acetate Sanilabs Inc. 80098769 6075 April 28, 2022 2020-06-06 Sanitagel Contains unacceptable ingredient, methanol Jefo Nutrition, Inc. 80098567 07820R414
08520R414
08720R414 March 2021 2020-07-03 Sanitagel Contains unacceptable ingredient, methanol Jefo Nutrition, Inc. 80098567 09020R414
09320R414 April 2021 2020-07-03 Sanix - Gel d'alcool pour les mains avec émollients, 70% alcool éthylique en format de 250 mL Contains unacceptable ingredient, methanol Sanix None All. Not printed on the label. Not printed on the label. 2020-10-13 Sanix - Gel d'alcool pour les mains avec émollients, 70% alcool éthylique en format de 4 L Contains unacceptable ingredient, methanol Sanix Mentions 80098684 All. Not printed on the label. Not printed on the label. 2020-10-13 Septeeze Contains unacceptable ingredient, ethyl acetate Les Produits Ultrapro, Inc. 80098001 0155505
0155405
0155805
0156505 May 2022 2020-07-21 Siding 14 Brewing Company - Ethanol Sanitizer 80% Missing risk statements; product not authorized to contain technical-grade ethanol Siding 14 Brewing Company Ltd. 80098925 20.036 to
20.073 Not printed on the label 2020-11-13 Silver Sanitizer Not authorized for sale in Canada 10932540 Canada, Inc. DBA Bio Life Sciences Corp. Unlicensed (no NPN or DIN on label) All All 2021-02-03 Smart Care Contains unacceptable ingredient, ethyl acetate R&D Technical Solutions Ltd. 80099110 005154
005155 May 2022 2020-06-10 Snake Lake Brewing Company - Ethanol Sanitizer 80% Missing risk statements; product not authorized to contain technical-grade ethanol Snake Lake Brewing Company, Inc. 80100225 0002 May 2022 2020-11-02 Solution Hydro-Alcoolique Pour Les Mains Missing risk statements; product not authorized to contain technical-grade ethanol 9376-5576 Québec Inc., DBA Les Produits PGM 80101326 03-06-22 June 2022 2020-08-21 Tekare Instant Hand Cleanser Gel Contains unacceptable ingredient, ethyl acetate TEKPolymer Inc. Unlicensed (no NPN or DIN on the label) HG200320 (not printed on the label) April 2023 2020-06-22 The 101 Coast Distillery Hand + Surface Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol; product not authorized for sanitizing hard surfaces Coast Distillery Ltd., DBA The 101 Brewhouse + Distillery 80098856 57
58
59
60
61
62
63
64 Not printed on the label 2020-11-27 Tidol Hand Sanitizer 70% Contains unacceptable ingredient, ethyl acetate Tidol Corporation 80099632 7080 April 2022 2020-06-10 Upstreet Do Gooder Hand Sanitizer 65% Contains unacceptable ingredient, ethyl acetate Upstreet Craft Brewing 80098137 A
B April 2022 2020-07-27 Upstreet Do Gooder Hand Sanitizer 80% Contains unacceptable ingredient, ethyl acetate Upstreet Craft Brewing 80100114 C April 2022 2020-07-27 Vima-San Contains unacceptable ingredient, ethyl acetate Crown Chemical Products, Inc. Unlicensed (no NPN or DIN on label) 02200
02270
03130
03310 Not printed on the label 2020-06-30 Vima-San Hand Sanitizer Contains unacceptable ingredient, ethyl acetate Green Dolphin Systems Corp. Unlicensed (no NPN or DIN on label) All. Lot number not printed on the label. Not printed on the label 2020-07-10 Visibly Clean Hand Sanitizer Not authorized for sale in Canada Brands International Corporation None All All 2020-06-24 Vitalpur Contains unacceptable ingredient, ethyl acetate Laboratoire Capillaire Guy Décaux 80100023 1
2
3
7
8
9
10 Not printed on the label 2020-07-10 Walker Emulsions Hand Sanitizer Contains unacceptable ingredient, ethyl acetate Walker Emulsions Ltd. 80098678 209638 Not printed on the label 2020-06-06 Weltel Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Tri Natural Mfg. 80099541 HS2005 May 2021 2020-09-14 X-Pure Vert-2-Go Gel Contains unacceptable ingredient, ethyl acetate Wood Wyant Inc. 80013648 109832
309132
408732
208732
109732
109232 April 2022 2020-06-10 Xero Germs Sold without proper testing National Therapy Products, Inc. 80100321 N20249 July 2022 2021-02-03Zytec Germ Buster Counterfeit product Northern National Sales, Inc. 80015625 3329733126 April 2022 2021-02-03 Désinfectant pour les mains à base d'éthanol 70% Missing risk statements; product not authorized to contain technical-grade ethanol Duvernois 80098158 200414
23/04/2020
19:34 to
30/04/2020
23:59
20005195
20005475
20005478
20005479
20005848
20005849
20005850
20006018
20006019
20006020
20005193
20005194
20005195
20005476
20005477
20005479
20005480
20005688
20005693
20006022
20006023 April 2022 2020-09-04 Désinfectant pour les mains à base d'éthanol 70% Missing risk statements; product not authorized to contain technical-grade ethanol Duvernois 80098158 200414
01/05/2020
00:00 to
01/05/2020
20:30
200414A
15/05/2020
16:30 to
21/05/2020
11:55 and
21/05/2020
22:35 to
25/05/2020
10:33
20006026
20006027 May 2022 2020-09-04 Gal Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol GAL Aviation Inc. 80098899 HS2804
HS2904
HS3004 April 2022 2020-08-21 Gal Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol GAL Aviation Inc. 80098899 HS0105
HS0405
HS0505
HS0605
HS0705
HS0805
HS1105
HS1205 May 2022 2020-08-21 Gal Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol GAL Aviation Inc. 80098899 HS0206
HS0306 June 2022 2020-08-21
Sours: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73385a-eng.php
75% alcohol disinfectant wipes factory in China , CE, FDA certificate . wechat :+8618751710146
Ardil Comercial SRL  Alcohol Isopropilico Hand Sanitizer Limar 77854-030-04Ardil Comercial SRLHand sanitizer product packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 6/16/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 6/30/2021; product recalled on 7/1/2021; FDA issued a warning letter on 09/22/202106/16/20214E Global SAPI de CV (Mexico)Blumen Clear Advanced Hand Sanitizer with 70% Alcohol with Glycerin and Aloe60599-018-00
60599-018-02
60599-018-044E Brands North America LLCFDA tested product; contains  methanol; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E60599-015-004E Brands North America LLCFDA tested product; contains methanol; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Advanced Instant Hand Sanitizer Clear with 70% Ethyl Alcohol with Glycerin & Vitamin E60599-015-01
60599-015-024E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/11/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)KLAR AND DANVER Instant Hand Sanitizer33992-8010-1Greenbrier International Inc.Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)MODESA Instant Hand Sanitizer Moisturizers and Vitamin E60599-007-33Midwood Brands LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Advanced Hand Sanitizer60599-012-04
60599-012-084E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Advanced Hand Sanitizer60599-012-00
60599-012-01
60599-012-02
60599-012-03
60599-012-05
60599-012-06
60599-012-07
60599-012-104E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Advanced Hand Sanitizer Aloe60599-013-00
60599-013-01
60599-014-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Advanced Instant Hand Sanitizer Lavender60599-016-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Clear Advanced Hand Sanitizer60599-018-02
60599-018-04
60599-018-06
60599-018-074E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Clear Advanced Hand Sanitizer60599-017-00
60599-018-01
60599-018-02
60599-018-04
60599-018-06
60599-018-07  4E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Clear LEAR Advanced Hand Sanitizer60599-017-00
60599-018-014E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Clear LEAR Advanced Hand Sanitizer60599-017-01
60599-018-03
60599-018-05
60599-018-08
60599-019-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)The Honeykeeper Hand Sanitizer60599-020-00
60599-020-014E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Advanced Hand Sanitizer Clear60599-024-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Clear Advanced Instant Hand Sanitizer60599-025-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Clear Advanced Instant Hand Sanitizer Aloe60599-026-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Clear Advanced Instant Hand Sanitizer Lavender60599-027-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol60599-028-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol60599-029-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; product voluntarily recalled on 7/11/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol60599-046-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol60599-047-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)Blumen Antibacterial Fresh Citrus Hand Sanitizer60599-501-014E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)Blumen Hand Sanitizer Fresh Citrus60599-502-014E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)KLAR and DANVER Instant Hand Sanitizer60599-801-00Greenbrier International Inc.Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)Hello Kitty Hand Sanitizer; this is not an official Sanrio licensed product  60599-802-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)Assured Instant Hand Sanitizer (Vitamin E and Aloe)60599-850-00Greenbrier International Inc.Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers07/08/20204E Global SAPI de CV (Mexico)Assured Instant Hand Sanitizer (Aloe and Moisturizers)60599-851-00Greenbrier International Inc.Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers07/08/20204E Global SAPI de CV (Mexico)Assured Instant Hand Sanitizer Vitamin E and Aloe60599-852-00Greenbrier International Inc.Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers07/08/20204E Global SAPI de CV (Mexico)Assured Instant Hand Sanitizer Aloe and Moisturizers60599-853-00Greenbrier International Inc.Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; product voluntarily recalled on 7/24/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers07/08/20204E Global SAPI de CV (Mexico)BLUMEN Instant Hand Sanitizer Fragrance Free60599-854-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)BLUMEN Instant Hand Sanitizer Aloe Vera60599-855-004E Brands North America LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/202007/08/20204E Global SAPI de CV (Mexico)Assured Aloe60599-999-10Greenbrier International Inc.Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/16/2020; FDA issued a warning letter on 10/23/2020; at this time, FDA cannot comment on Assured brand hand sanitizers made by other manufacturers07/08/2020AAA Cosmetica (Mexico)bio aaa Advance Hand Sanitizer 76987-402-01
74840-402-01Payless Janitorial CorporationFDA tested product; contains methanol; FDA recommended the company recall on 7/2/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/7/2020; product voluntarily recalled on 7/14/2020; FDA issued a warning letter on 2/3/202107/06/2020AAA Cosmetica (Mexico)bio aaa Advance Hand Sanitizer 480 mL bottlesNot listedAJR Trading LLCProduct purported to made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/26/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/7/2020; product voluntarily recalled on 9/3/2020; FDA issued a warning letter on 2/3/202109/04/2020AAA Cosmetica (Mexico)LumiSkin Advance Hand Sanitizer76987-120-01Soflo Urban Team LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/7/2020; FDA issued a warning letter on 2/3/202107/06/2020AAA Cosmetica (Mexico)LumiSkin Advance Hand Sanitizer76987-402-02Soflo Urban Team LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/7/2020; FDA issued a warning letter on 2/3/202107/06/2020AAA Cosmetica (Mexico)QualitaMed Hand Sanitizer76987-250-01QualitaMed Corp.Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/2/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/7/2020; FDA issued a warning letter on 2/3/202107/06/2020Albek de Mexico SA de CV (Mexico)NEXT Hand Sanitizer50066-605-08Genomma Lab USAFDA tested product; contains methanol; FDA recommended a recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/202107/28/2020Albek de Mexico SA de CV (Mexico)NuuxSan Instant Antibacterial Hand Sanitizer72758-001-08
72758-002-08Albek de Mexico SA de CVProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/202107/28/2020Albek de Mexico SA de CV (Mexico)NuuxSan Instant Hand Sanitizer72758-003-00
72758-003-01
72758-005-01
72758-005-02
72758-005-03Albek de Mexico SA de CVProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/202107/28/2020Albek de Mexico SA de CV (Mexico)Assured Instant Antiseptic Hand Sanitizer with Aloe and Moisturizers72758-009-23Albek de Mexico SA de CVProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/202107/28/2020Albek de Mexico SA de CV (Mexico)Assured Instant Antiseptic Hand Sanitizer with Vitamin E and Aloe72758-010-23Albek de Mexico SA de CVProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/202107/28/2020Albek de Mexico SA de CV (Mexico)Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Aloe Vera72758-011-23Albek de Mexico SA de CVProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/202107/28/2020Albek de Mexico SA de CV (Mexico)Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Vitamin E72758-012-23Albek de Mexico SA de CVProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/27/2020; product voluntarily recalled on 7/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/4/2020; FDA issued a warning letter on 3/11/202107/28/2020Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico)Argent Defense Group Hand Sanitizer  77927-100-07
77927-100-11ABN CorporationFDA tested product; contains methanol; FDA recommended the company recall on 8/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; FDA issued a warning letter on 2/22/202109/01/2020Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico)Dolphin Hands Sanitizer77927-100-04
77927-100-08Asesores en Mantenimiento Hidrulico e Industrial, SA de CV (Mexico)Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 08/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; FDA issued a warning letter on 2/22/202109/01/2020Asesores en Mantenimiento Hidrulico e Industrial SA de CV (Mexico)Hand Sanitizer Antiseptic Hand Gel 70-277927-100-05
77927-100-06
77927-100-09
77927-100-10Asesores en Mantenimiento Hidrulico e Industrial, SA de CV (Mexico)Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 08/31/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; FDA issued a warning letter on 2/22/202109/01/2020Asiaticon SA de CV (Mexico)V-KLEAN Hand Sanitizer GelNot listedAstrum LLCFDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/202008/06/2020Asiaticon SA de CV (Mexico)V-KLEAN Hand Sanitizer Gel75192-001-01
75192-002-04AsiaticonProduct purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/202008/06/2020Asiaticon SA de CV (Mexico)V-KLEAN Hand Sanitizer Gel75192-002-01
75192-002-02Acadia Mercantil Corp.Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/202008/06/2020Asiaticon SA de CV (Mexico)V-KLEAN Hand Sanitizer Gel75192-002-03Protex LabsProduct purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/202008/06/2020Asiaticon SA de CV (Mexico)DermX70 Hand Sanitizer (only includes 250mL, 500mL and 1000mL sized packages)75192-003-01
75192-003-02
75192-003-03Protex LabsProduct purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA issued a warning letter on 10/29/202008/06/2020Asiaticon SA de CV (Mexico)V-KLEAN75192-100-01SWCH LLCProduct purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/202008/06/2020Asiaticon SA de CV (Mexico)Medically Minded Hand Sanitizer Gel75192-500-01
75192-600-01SBL Brands LLC dba Global Sanitizers LLC (Nevada) LLC dba Global Sanitizers LLC (Nevada)Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/202008/06/2020Asiaticon SA de CV (Mexico)Protz Real Protection Antibacterial Hand Sanitizer75192-600-02Safety-Med ProductsProduct purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled on 8/25/2020; FDA issued a warning letter on 10/29/202008/06/2020Bionateo Sp z.o.o.
(Poland)Altaio Hand Sanitizing Gel78571-002-02  Bionateo Sp z.o.o. (Poland)  FDA tested product; contains methanol; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 6/7/2021  05/26/2021Bionateo Sp z.o.o. (Poland)Altaio Hand Sanitizing Gel78571-002-01
78571-002-03
78571-002-04
78471-002-05Bionateo Sp z.o.o.
(Poland)Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 6/7/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 6/7/202105/26/2021Bionateo Sp z.o.o. (Poland)Altaio Hand Sanitizer Topical Solution78581-001-01
78581-001-02
78581-001-03
78581-001-04
78571-001-05
78571-001-06Bionateo Sp z.o.o. (Poland)Product purported to be made at the same facility that produced methanol contaminated product; FDA has been unable to contact the manufacturer or the distributor to recommend the company recall its product; added manufacturer to import alert to help stop their products from entering the U.S. on 6/7/202105/26/2021Botanicals Internacional SA de CV (Mexico)Alcohol Antiseptic 80% topical solution hand sanitizer51384-001-01
51384-001-02Pure HavenProduct purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/202108/06/2020Botanicals Internacional SA de CV (Mexico)Inatek Hand Sanitizer Non-Sterile Solution 70% of Alcohol51384-002-01Inambtec SA de CVFDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/202108/06/2020Botanicals Internacional SA de CV (Mexico)All Clear Hand Sanitizer Fragrance Free51384-004-01Good Fibers LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/202108/06/2020Botanicals Internacional SA de CV (Mexico)Total Pure Alcohol Based Hand Sanitizer Gel51384-003-01
51384-003-02Product purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/202108/06/2020Botanicals Internacional SA de CV (Mexico)70% Alcohol Gel Hand Sanitizer51384-500-10
51384-500-11
51384-500-23
51384-500-47
51384-500-94USMed Supplies LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/202108/06/2020Botanicals Internacional SA de CV (Mexico)ResQue 1st Instant Hand Sanitizer73762-100-10
73762-100-11
73762-100-23
73762-100-47
73762-100-94Quick Aid LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/202108/06/2020Botanicals Internacional SA de CV (Mexico)70% Alcohol Gel Hand Sanitizer78072-400-10
78072-400-11
78072-400-23
78072-400-47
78072-400-94LTD Enterprises DistributionProduct purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/202108/06/2020Botanicals Internacional SA de CV (Mexico)70% Alcohol Gel Hand Sanitizer78072-500-10
78072-500-11
78072-500-23
78072-500-47
78072-500-94USMed Supplies LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 2/3/202108/06/2020Broncolin SA de CV (Mexico)Herbacil Antiseptic Hand Sanitizer 70% Alcohol62583-020-08INBC Trading LLCFDA tested product; contains methanol; FDA recommended the company recall on 7/24/2020; product voluntarily recalled on 7/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/29/2020; FDA issued a warning letter on 12/21/202007/24/2020Broncolin SA de CV (Mexico)Herbacil Antiseptic Hand Sanitizer 70% Alcohol62583-020-16
62583-020-33
62583-020-42INBC Trading LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/24/2020; product voluntarily recalled on 7/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/29/2020; FDA issued a warning letter on 12/21/202007/24/2020Broncolin SA de CV (Mexico)Herbacil Antiseptic Hand Sanitizer 70% Alcohol74673-001-08
74673-001-16
74673-001-33
74673-001-42INBC Trading LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 7/24/2020; product voluntarily recalled on 7/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/29/2020; FDA issued a warning letter on 12/21/202007/24/2020C&G Laboratorios SA de CV (Mexico)Hand Sanitizer Disenfectant GelNot ListedAccess USAFDA tested product; contains methanol; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/9/202010/01/2020Corporativo Bureli SA de CV (Mexico)Soho Fresh Hand Sanitizer Gel Antibacterial79081-000-03SOHO FreshFDA tested product; contains methanol; FDA recommended the company recall on 9/15/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/24/2020; FDA issued a warning letter on 12/1/202009/16/2020Corporativo Bureli SA de CV (Mexico)SOHO Fresh Hand Sanitizer Gel Antibacterial79081-000-01
79081-000-02
79081-000-04
78533-000-02
78533-000-08
78533-000-16
78533-000-33SOHO Fresh and Essaar Inc.Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 9/15/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/24/2020; FDA issued a warning letter on 12/1/202009/16/2020Corporativo Bureli SA de CV (Mexico)SOHO Fresh Rubbing Alcohol78533-001-33SOHO FreshProduct purported to be made at the same facility that produced methanol contaminated product; Product voluntarily recalled by Essaar Inc. on 1/4/2021; added manufacturer to import alert to help stop their products from entering the U.S. on 9/24/2020; FDA issued a warning letter on 12/1/202001/11/2021DDI Multinacional SA de CV (Mexico)Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced74949-002-20
74949-002-25
74949-002-49
74949-002-60Earths AmenitiesFDA tested product; contains methanol; product retained at the border; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/13/202007/08/2020DDI Multinacional SA de CV (Mexico)Hand Sanitizer Agavespa Skincare77415-000-00Vidanos Easy Cleaning RentalsFDA tested product; contains methanol; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/13/202007/08/2020DDI Multinacional SA de CV (Mexico)Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare77056-000-01Vidanos Easy Cleaning RentalsProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall of all other potential products on the market on 6/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/13/202007/08/2020DEPQ Internacional S de RL de CV (Mexico)dgreen Advanced Sanitizer Alcohol Free74155-211-04
74155-211-07
74155-211-08
74155-211-19
74155-211-20
74155-211-38  Biokaab Inc.FDA tested product; benzalkonium chloride level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 7/31/2020; FDA issued a warning letter on 3/18/202108/03/2020DEPQ Internacional S de RL de CV (Mexico)dgreen Advanced Hand Sanitizer Antibacterial Gel74155-201-03
74155-201-19
74155-201-20
74155-201-38  Biokaab Inc.Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 7/31/2020; FDA issued a warning letter on 3/18/202108/03/2020DEPQ Internacional S de RL de CV (Mexico)Hand Sanitizer74155-111-07
74155-111-08
74155-111-19
74155-111-20
74155-111-38Biokaab Inc.Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 7/31/2020; FDA issued a warning letter on 3/18/202108/03/2020DEPQ Internacional S de RL de CV (Mexico)Hand Sanitizer Gel74155-101-07
74155-101-08
74155-101-19
74155-101-20
74155-101-38Biokaab Inc.Product purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 7/31/2020; FDA issued a warning letter on 3/18/202108/03/2020DEPQ Internacional S de RL de CV (Mexico)Clean Humans Hand SanitizerNot listedProduct purported to be made at the same facility that produced subpotent benzalkonium chloride product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 7/31/2020; FDA issued a warning letter on 3/18/202108/03/2020Dibar Nutricional S De RL de CV (Mexico)Dibar Labs Hand Sanitizer73009-001-08S.E.N.D. LLCFDA tested product; contains methanol; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily recalled on 5/11/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/202104/29/2021Dibar Nutricional S De RL de CV (Mexico)Dibar Labs Hand Sanitizer  73009-001-16
73009-003-04
73009-003-32S.E.N.D. LLCProduct purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily recalled on 5/11/2021; recall expanded on 05/18/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/202104/29/2021Dibar Nutricional S De RL de CV (Mexico)ProtectoRx Hand Sanitizer Extra Strength73009-002-01
73009-002-02
75408-002-01
75408-002-02PR Trading LLCProduct purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily recalled on 5/11/2021; recall expanded on 05/18/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/202104/29/2021Dibar Nutricional S De RL de CV (Mexico)Eztizer Hand Sanitizer73009-005-01
73009-005-02
73009-005-03
73009-005-04
73009-005-05
73009-005-06Dibar LabsProduct purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/202104/29/2021Dibar Nutricional S De RL de CV (Mexico)Advance Hand Sanitizer73009-010-00
79284-005-00Lifetime Health ServicesProduct purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; product voluntarily recalled on 5/18/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/202104/29/2021Dibar Nutricional S De RL de CV (Mexico)Basic Care Gel Hand Sanitizer73009-015-01
73009-015-02
79695-015-01
79695-015-02Nora Foods Inc.Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/202104/29/2021Dibar Nutricional S De RL de CV (Mexico)Genesis Today Advanced Hand Sanitizer73009-016-01
62400-0016-1West Town BrandsProduct purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/202104/29/2021Dibar Nutricional S De RL de CV (Mexico)Wellnicity Hand Sanitizer73009-017-01
62400-0017-1WellnicityProduct purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/202104/29/2021Dibar Nutricional S De RL de CV (Mexico)Bklen Hands Sanitizer73009-018-01
73009-018-02
73009-018-03
73009-018-04
73009-018-05
81081-000-01
81081-000-02
81081-000-03
81081-000-04
81081-000-05Garflo FoodsProduct purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert (66-40) to help stop their products from entering the U.S. on 11/06/2020; FDA issued a warning letter on 03/10/2021; FDA recommended the company recall on 4/27/2021; recall expanded on 05/18/2021; firm added to import alert (66-78) on 6/22/202104/29/2021Distribuidora Lagunera del Norte SA de CV (Mexico)Weper Clean Solutions  76527-001-03  Ekko’s Venture LLC  FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 3/10/2021; FDA issued a warning letter on 3/23/202101/28/2021Distribuidora Lagunera del Norte SA de CV (Mexico)Weper Clean Solutions  76527-001-01
76527-001-02
76527-001-04
76527-001-05
76527-001-06
76527-001-07  Ekko’s Venture LLC  Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 3/10/2021; FDA issued a warning letter on 3/23/202101/28/2021Distribuidora Lagunera del Norte SA de CV (Mexico)CyroLab Q&T Antibacterial Gel  78907-001-01
78907-001-02
78907-001-03
78907-001-04
78907-001-05  Distribuidora Lagunera del Norte SA de CV  Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 3/10/2021; FDA issued a warning letter on 3/23/202101/28/2021Distribuidora Lagunera del Norte SA de CV (Mexico)Kleengel Hand Sanitizer  76527-002-01
76527-002-02
76527-002-03
76527-002-04
76527-002-05
76527-002-06
76527-002-07
76527-002-02  Comdata Laguna S de RL de CV  Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 3/10/2021; FDA issued a warning letter on 3/23/202101/28/2021Distribuidora Lagunera del Norte SA de CV (Mexico)Kilvir Forte Virus Killer  76527-003-01
76527-003-02
76527-003-03
76527-003-04
76527-003-05
76527-003-06
76527-003-07
76527-003-08  Comdata Laguna S de RL de CV  Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 3/10/2021; FDA issued a warning letter on 3/23/202101/28/2021DMM Vission SA de CV (Mexico)SYP Health Hand Sanitizer Alcohol Gel75799-000-03FDA tested product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; FDA issued a Warning Letter on 06/03/202108/21/2020DMM Vission SA de CV (Mexico)Cleaner by Crystalware Hand Sanitizer Alcohol Gel74840-402-05CrystalWareFDA tested product; FDA recommended the company recall on 8/21/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; product voluntarily recalled by AA Products on 9/24/2020; FDA issued a Warning Letter on 06/03/202108/21/2020DMM Vission SA de CV (Mexico)Cleaner by Crystalware Hand Sanitizer Alcohol Gel75799-000-02
75799-000-04CrystalWareProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/21/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; product voluntarily recalled on 9/8/2020; FDA issued a Warning Letter on 06/03/202108/21/2020DMM Vission SA de CV (Mexico)SYP Health Hand Sanitizer Alcohol Gel75799-000-01Product purported to be made at the same facility that produced methanol contaminated product; contains methanol; FDA recommended the company recall on 8/21/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/2020; product voluntarily recalled by AA Products on 9/24/2020; FDA issued a Warning Letter on 06/03/202108/21/2020Eskbiochem SA de CV (Mexico)CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol74589-009-01ESPMEX LLCFDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/202007/02/2020Eskbiochem SA de CV (Mexico)Lavar 70 Gel Hand Sanitizer74589-006-01Blue Ridge Southern Supply LLCFDA tested product; contains methanol; FDA recommended the company recall on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/202007/02/2020Eskbiochem SA de CV (Mexico)All-Clean Hand Sanitizer74589-002-01All Clean Natural LTDProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; product voluntarily recalled by ITECH 361 on 7/6/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/202007/02/2020Eskbiochem SA de CV (Mexico)Esk Biochem Hand Sanitizer74589-007-01EskBiochemProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/202007/02/2020Eskbiochem SA de CV (Mexico)The Good Gel Antibacterial Gel Hand Sanitizer74589-010-10EskBiochem SA de CVProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/202007/02/2020Eskbiochem SA de CV (Mexico)CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol74589-005-03ESPMEX LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/202007/02/2020Eskbiochem SA de CV (Mexico)CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol74589-003-01ESPMEX LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/202007/02/2020Eskbiochem SA de CV (Mexico)Saniderm Advanced Hand Sanitizer74589-001-01Polarized LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall all other products potentially on the market on 6/17/2020; product voluntarily recalled by Saniderm Products on 6/26/2020 and UVT Inc. on 6/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/15/2020; FDA issued a warning letter on 7/23/202007/02/2020Estrategia Hospitalaria SA de CV (Mexico)OZO Hand Sanitizer, Luxury FormulaNot listedAncorp Capital Group USAFDA tested product; contains methanol; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/14/202008/06/2020Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico)  Pristine Hand Sanitizer Gel76938-001-01Universal Distributors LLCFDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/22/2020; FDA issued a warning letter on 3/1/202111/20/2020Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico)  Pristine Hand Sanitizer Gel76938-001-02
76938-001-03Universal Distributors LLCProduct purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/22/2020; FDA issued a warning letter on 3/1/202111/20/2020Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico)  Zapien Productos Hand Sanitizer Gel76938-100-02Gaza Proveedora de Servicios de Hospedaje y Alimentacion (Mexico)  Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 11/20/2020; product voluntarily recalled on 12/8/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 12/22/2020; FDA issued a warning letter on 3/1/202111/20/2020Genesis Partnership Company SA (Guatemala)Panagel Hand Sanitizer78384-001-01
72384-001-02
78384-001-03
78384-001-04Central-Med Distribution Inc.FDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/202008/28/2020Genesis Partnership Company SA (Guatemala)Panagel Hand Sanitizer74625-002-01
74625-002-04
74625-002-05
74625-003-01
74625-003-04
74625-003-05Killz Germz LLCProduct purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/202008/28/2020Genesis Partnership Company SA (Guatemala)Panagel Hand Sanitizer76988-001-01
76988-001-03DJR TradingProduct purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/202008/28/2020Genesis Partnership Company SA (Guatemala)SensiMedical Hand Sanitizer Gel78718-763-01
78718-763-02
78718-763-03
78718-763-04
78718-763-05
78718-763-06Sensimedical LLCProduct purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/202008/28/2020Genesis Partnership Company SA (Guatemala)Genesis Hand Sanitizer Gel74484-001-01
74484-001-02
74484-001-03
74484-001-04
74484-002-01
74484-002-02
74484-002-03
74484-002-04
74484-002-05
74484-002-06Genesis Partnership Company SA (Guatemala)Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/202008/28/2020Genesis Partnership Company SA (Guatemala)Medtek Supplies Hand Sanitizer78901-001-01Wide Evolution SystemsProduct purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA recommended the company recall on 8/27/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 9/2/202008/28/2020Genesis Partnership Company SA (Guatemala)Bathletix HAND SANITIZER74484-002-01; 74484-002-02BH Deals & Closeout, Inc.Hand sanitizer products packaged in containers resembling a water bottle that presents increased risk of accidental ingestion; FDA recommended a recall on 09/08/2021.09/08/2021Grupo Asimex de Mexico SA de CV (Mexico)  Florance Morris Body Care Antispetic Hand Sanitizer76612-170-06
76612-170-10
76612-170-11
76612-170-12
76612-170-25
76612-170-37
76612-170-50
76612-180-10
76612-180-12
76612-180-25
76612-180-37
76612-180-50Asimex International LLCFDA tested product; contains methanol; FDA recommended the company recall on 8/13/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/17/2020; product voluntarily recalled on 8/17/2020; FDA issued a warning letter on 11/6/202008/13/2020Grupo Asimex de Mexico Sa de CV (Mexico)Florance Morris Body Care Antispetic Hand Sanitizer77409-170-06
77409-170-10
77409-170-11
77409-170-12
77409-170-25
77409-170-37
77409-170-50
77409-180-10
77409-180-12
77409-180-25
77409-180-37
77409-180-50Asimex International LLCFDA tested product; contains methanol; FDA recommended the company recall on 8/13/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/17/2020; product voluntarily recalled on 8/17/2020; FDA issued a warning letter on 11/6/202008/13/2020Grupo Asimex de Mexico Sa de CV (Mexico)Florance Morris Body Care Antispetic Hand Sanitizer79109-170-06
79109-170-10
79109-170-11
79109-170-12
79109-170-22
79109-170-25
79109-170-37
79109-170-50Roldan IndustriesProduct purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 8/17/2020; product voluntarily recalled on 8/17/2020; FDA issued a warning letter on 11/6/202008/13/2020Grupo Insoma S.A.P.I de CV (Mexico)Hand sanitizer Gel Unscented 70% Alcohol75744-0200-3
75744-0200-4
75744-0201-5
75744-0202-1
75744-0250-1
75744-0250-2
75744-0500-1
75744-1000-1
75744-1000-3
75744-1001-1Grupo Insoma S.A.P.I de CVFDA tested product; contains methanol; FDA recommended the company recall on 7/1/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 10/23/202007/02/2020Grupo Insoma S.A.P.I de CV (Mexico)Hand sanitizer Gel Unscented 70% AlcoholNot listedCIRG Waste & Recycling Solutions US LLCFDA tested product; contains methanol; FDA recommended the company recall on 8/5/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 7/10/2020; FDA issued a warning letter on 10/23/202008/06/2020Grupo Plast Y Kosas SA de CV (Mexico)M Hand Sanitizer Alcohol Antiseptic topical solution 80% Topical Solution Hand Sanitizer75432-001-02Medek LLCFDA tested product; contains methanol; FDA recommended the company recall on 8/20/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; product voluntarily recalled by Medek LLC on 9/9/2020; FDA issued a warning letter on 1/25/202108/11/2020Grupo Plast Y Kosas Sa De CV (Mexico)Hand Sanitizer Alcohol Antiseptic topical solution 80%77797-001-01
75432-001-01  Medek LLCProduct purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA issued a warning letter on 1/25/202108/11/2020Grupo Plast Y Kosas SA de CV (Mexico)  Jalisco Paper Inc. Restaurant Supplies Hand Sanitizer77797-001-02
75432-001-03Medek LLCFDA tested product; ethyl alcohol level was subpotent; product was manufactured at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA issued a warning letter on 1/25/202108/11/2020Grupo Plast Y Kosas SA de CV (Mexico)  O.K. Pharmacy Hand Sanitizer77797-001-03
75432-001-04Medek LLCFDA tested product; ethyl alcohol level was subpotent; product was manufactured at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/20/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/11/2020; FDA issued a warning letter on 1/25/202108/11/2020Grupo Yacana Mexico SAS de CV (Mexico)Yacana Alcohol Antiseptic 70% Topical Solution76592-002-01
76592-002-02
76592-002-03
76592-002-04
76592-002-05
76592-002-06
76592-002-07Greensys of North America LLCFDA tested product; contains methanol; FDA recommended the company recall on 8/12/2020; product voluntarily recalled on 8/18/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/20/2020; FDA issued a warning letter on 1/26/202108/13/2020Grupo Yacana Mexico SAS de CV (Mexico)Yacana Isopropyl Alcohol Antiseptic 70% Topical Solution76592-001-01
76592-001-02
76592-001-03
76592-001-04Greensys of North America LLCFDA tested product; isopropyl alcohol level was subpotent; FDA recommended the company recall on 8/12/2020; product voluntarily recalled on 8/18/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/20/2020; FDA issued a warning letter on 1/26/202108/13/2020Grupo Yacana Mexico SAS de CV (Mexico)Yacana Clase Mundial Isopropyl Alcohol Antiseptic 70% Topical Solution or Gel76592-003-01
76592-003-02
76592-004-01
76592-004-02Product purported to be made at the same facility that produced methanol contaminated product; FDA recommended the company recall on 8/12/2020; product voluntarily recalled on 8/18/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/20/2020; FDA issued a warning letter on 1/26/202108/13/2020Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)IMC Wash-Free Hand Sanitizer  Not listed  IMC  FDA tested product; contains methanol; product voluntarily recalled by Shane Erickson on 12/23/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the manufacturer recall on 1/25/202012/15/2020Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)  Yuame Wash-Free Hand Sanitizer Gel  75132-001-01
75132-001-02
75132-001-03
75132-001-04
75132-001-05
75132-001-06
75132-001-07
75132-001-08
75132-001-09
75132-001-10
75132-001-11
75132-001-12
75132-001-13
75132-001-14
75132-001-15
75132-001-16
75132-001-17Guangdong Kemei Pharmaceutical Technology Co. LtdProduct purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/202012/15/2020Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)  Yuame 75% Alcohol Disinfectant  75132-002-01
75132-002-02
75132-002-03
75132-002-04
75132-002-05
75132-002-06
75132-002-07
75132-002-08
75132-002-09
75132-002-10Guangdong Kemei Pharmaceutical Technology Co. LtdProduct purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/202012/15/2020Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)  Yuame Wash-Free Hand Sanitizer Gel  75132-011-01
75132-011-02
75132-011-03  Guangdong Kemei Pharmaceutical Technology Co. LtdProduct purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/202012/15/2020Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)  KLEAN KARE Hand Sanitizer Industrial and Hospital Grade  77205-001-01
77205-001-02  AMG LLC  Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/202012/15/2020Guangdong Kemei Pharmaceutical Technology Co. Ltd. (China)  Essentials, M.D. Hand Sanitizer Industrial and Hospital Grade  77205-002-01
77205-002-02  AMG LLC  Product purported to be made at the same facility that produced methanol contaminated product; added manufacturer to import alert to help stop their products from entering the U.S. on 1/7/2021; FDA recommended the company recall on 1/25/202012/15/2020Guangzhou Minghui Cosmetics Co. Ltd. (China)Qi Yu Hand Sanitizer74447-012-01Guangzhou Minghui Cosmetics Co. Ltd.FDA tested product; ethyl alcohol level was subpotent; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021.04/12/2021

Guangzhou Minghui Cosmetics Co. Ltd. (China)

Qi Yu Hand Sanitizer

74447-001-01 

74447-002-01 

74447-003-01 

74447-004-01 

74447-005-01 

74447-006-01 

74447-007-01 

74447-008-01 

74447-009-01 

74447-010-01 

74447-011-01 

74447-012-02 

74447-012-03 

74447-012-04 

74447-012-05 

74447-012-06 

74447-012-07 

74447-012-08 

74447-012-09 

74447-012-10 

Guangzhou Minghui Cosmetics Co. Ltd.

Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021.

04/12/2021

Guangzhou Minghui Cosmetics Co. Ltd. (China)

Qi Yu Medical Alcohol Disinfectant

74447-101-01 

74447-101-02 

74447-101-03 

74447-101-04 

74447-101-05 

74447-101-06 

74447-101-07 

74447-101-08 

74447-101-09 

74447-101-10 

74447-101-11 

74447-101-12 

74447-101-13 

74447-101-14 

74447-101-15 

74447-101-16 

74447-101-17 

Guangzhou Minghui Cosmetics Co. Ltd. 

Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021.

04/12/2021

Guangzhou Minghui Cosmetics Co. Ltd. (China)

Waxman Kleen Freak Hand Sanitizer

74447-106-01 

Waxman Industries 

Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021.

04/12/2021Guangzhou Youxing Cosmetics Co. Ltd.(China)  V&W Advance Hand Sanitizer Refreshing Gel  75239-005-09  Val USA Manufacturer Inc.FDA tested product; ethyl alcohol level was subpotent; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/202110/01/2020Guangzhou Youxing Cosmetics Co. Ltd. (China)  V&W Advance Hand Sanitizer Refreshing Gel  75239-005-01
75239-005-02
75239-005-03
75239-005-04
75239-005-05
75239-005-06
75239-005-07
75239-005-08
75239-005-10
75239-005-11
75239-005-12
75239-005-13
75239-005-14
75239-005-15
75239-005-16
75239-005-17Val USA Manufacturer Inc.  Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/202110/01/2020Guangzhou Youxing Cosmetics Co. Ltd. (China)  V&W Moisturizing Refreshing Spray Sanitizer [isopropyl alc.]  75239-006-01
75239-006-02
75239-006-03
75239-006-04
75239-006-05
75239-006-06
75239-006-07
75239-006-08
75239-006-09
75239-006-10
75239-006-11
75239-006-12
75239-006-13
75239-006-14
75239-006-15
75239-006-16
75239-006-17
75239-006-18
75239-006-19
75239-006-20Val USA Manufacturer Inc.  Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/2021.10/01/2020Guangzhou Youxing Cosmetics Co. Ltd. (China)  V&W Premium Disinfecting Wipes  75239-007-01  Val USA Manufacturer Inc.  Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/2021.10/01/2020Guangzhou Youxing Cosmetics Co. Ltd. (China)  V&W Advance Hand Sanitizer Refreshing Gel  76687-005-01
76687-005-02
76687-005-03
76687-005-04
76687-005-05
76687-005-06
76687-005-07
76687-005-08
76687-005-09
76687-005-10
76687-005-11
76687-005-12
76687-005-13
76687-005-14
76687-005-15
76687-005-16
76687-005-17
76687-005-18
76687-005-19
76687-005-20Val USA Manufacturer Inc.  Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/2021.10/01/2020Guangzhou Youxing Cosmetics Co. Ltd. (China)  V&W Moisturizing Refreshing Spray Sanitizer [isopropyl alc.]  76687-006-01
76687-006-02
76687-006-03
76687-006-04
76687-006-05
76687-006-06
76687-006-07
76687-006-08
76687-006-09
76687-006-10
76687-006-11
76687-006-12
76687-006-13
76687-006-14
76687-006-15
76687-006-16
76687-006-17
76687-006-18
76687-006-19
76687-006-20Val USA Manufacturer Inc.  Product purported to be made at the same facility that produced subpotent ethyl alcohol product; FDA has no evidence this product is in the U.S. market; added manufacturer to import alert to help stop their products from entering the U.S. on 10/8/2020; FDA issued a warning letter on 09/30/2021.10/01/2020Guangzhou Minghui Cosmetics Co. Ltd. (China) Qi Yu Hand Sanitizer 
74447-010-01Guangzhou Minghui Cosmetics Co. Ltd. 

Product purported to be made at the same facility that produced subpotent ethyl alcohol product; added to import alert to help stop products from entering the U.S. on 12/21/2020; FDA recommended the company recall on 4/12/2021; FDA issued a warning letter on 07/06/2021; product voluntarily recalled by Native Promotions, Inc. on 7/12/2021

7/21/2021Harmonic Nature S de RL de MI (Mexico)Alcohol Antiseptic 75% Topical Solution Hand Sanitizer76949-234-01
76949-234-02
76949-235-01
76949-235-02FDA tested product; contains 1-propanol; FDA recommended the company recall on 8/12/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/20/2020; product voluntarily recalled on 8/14/2020; FDA issued a warning letter on 11/16/202008/12/2020Healthy Foods & Nutrition Lab de Mexico SA de CV (Mexico)HF&N Lab Medi Care Alcohol Antiseptic Topical Solution77740-000-00 77740-000-01 77740-000-02 77740-001-00 77740-001-01 77740-001-02Healthy Food and Nutrition LabFDA tested product; ethyl alcohol level was subpotent; FDA recommended the company recall on 7/29/2020; added manufacturer to import alert to help stop their products from entering the U.S. on 8/13/2020; FDA issued a warning letter on 09/29/202107/30/2020Hou Fu Biotech (Jiansu) Co. Ltd. (China)PANROSA Instant Hand Sanitizer Aloe Vera76766-001-01 Panrosa Enterprise Inc.
Sours: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use

Safe alcohol wipes from china

Chinese Wipes Maker Flagged by FDA

Xi’an Livingbond Nonwoven Products Corp., Ltd., China, has been issued a warning letter by the US FDAfollowing an inspection of its drug manufacturing facility at Fengjing Ind Park, Hu District, Xian Shaanxi from January 7-10, 2019, where product such as antibacterial wet wipes are produced for the US market.

FDA says it found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. 

Based on FDA review, the company’s products, Antibacterial Wet Wipes (in four separate package configurations) are also misbranded under section 502(x) of the FD&C Act, 21 U.S.C. 352(x). Introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

The inspection found that the company did not test its over-the-counter (OTC) finished drug products to determine whether each batch meets identity and strength specifications before releasing those products to the U.S. market.

In addition, the firm lacked reliable testing for microbial attributes. For example, FDA said the company did not have an adequate program for growth promotion testing of media used for microbial testing. 
FDA said that that in its response, the firm  stated that it will send each finished product batch to a third party to test for active ingredient identity and strength prior to release, and that it also stated plans to purchase a chromatographic analyzer.  

“We acknowledge your commitment to perform growth promotion test on each batch of media to assure the reliability of the microbiological results,” penned FDA in its letter. However it said,the response is “inadequate because it did not commit to take any corrective action for products already in the market, include information about your third-party testing laboratory, or provide procedures to be used for additional testing. You must ensure each batch of your drug products meets all chemical and microbiological specifications before release.”

FDA has asked the firm provide:
·      A list of all chemical and microbial test methods and specifications used to analyze each batch of your drug products before making the batch disposition decision, and associated written procedures. 
·      A summary of test results obtained from retrospective testing of retain samples of all drug product batches currently in distribution in the United States. Include test results for identity and strength of active ingredients, and all other appropriate chemical and microbial quality attributes. If you released any batch that was out of specification, indicate the corrective action you will take, such as customer notifications and product recalls. 
·      A comprehensive and independent review of your laboratory practices, procedures, methods, equipment and analyst competencies. Based on this review, provide a detailed corrective action and preventive action (CAPA) plan to fully remediate your laboratory system. Your plan should also include the procedures you will use to evaluate the effectiveness of the implemented CAPA.
·      Provide your procedure to assure that any test methods performed by a contract testing laboratory on your behalf are properly transferred and validated before use. 
 
Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and that the consultant evaluates the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. 
 
Antibacterial Wet Wipes are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or as defined under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Specifically, these products are intended as consumer antiseptic rubs.
   
FDA placed the company on Import Alert 66-40 on April 12, 2019. 

Until Xi’an Livingbond Nonwoven Products Corp correct sall violations completely and FDA confirms compliance with CGMP, the agency may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. 

Sours: https://www.happi.com/contents/view_breaking-news/2019-07-03/chinese-wipes-maker-flagged-by-fda/
Anti Bacterial Wet Wipes (Alcohol Pads)

More hand sanitizers identified for methanol risk and added to FDA list of ones to avoid

The Food and Drug Administration's list of hand sanitizers to avoid keeps growing.

As of Friday, the FDA's "do-not-use list of dangerous hand sanitizer products" now includes more than 150 varieties of hand sanitizer that should be avoided because they may contain methanol, a potentially fatal ingredient, contain other harmful ingredients or don't work effectively.

More of the hand sanitizers have been recalled with others being recommended for recall. Methanol is a toxic substance when absorbed through skin or ingested.

The federal agency says that in most cases, methanol does not appear on the product label but that it is "not an acceptable ingredient in any drug, including hand sanitizer, even if methanol is listed as an ingredient on the product label."

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Methanol isn't the only reason why some hand sanitizers were added to the FDA's list.

"FDA continues to find issues with certain hand sanitizer products. FDA test results show certain hand sanitizers have concerningly low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in hand sanitizer products," the federal agency said. "The agency urges consumers not to use these subpotent products and has expanded its list to include subpotent hand sanitizers, in addition to hand sanitizers that are or may be contaminated with methanol."

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Some of the sanitizers on the list "have tested positive for 1-propanol contamination," which "is not an acceptable ingredient for hand sanitizer products marketed in the United States and can be toxic and life-threatening when ingested."

The agency said that young children who ingest 1-propanol can experience central nervous system (CNS) depression, which can be deadly. Other symptoms include "confusion, decreased consciousness, and slowed pulse and breathing," as well as skin irritation or allergic reactions, the FDA said.

In a warning July 27, the FDA said it is "urging consumers not to use any hand sanitizer products from the particular manufacturers on the list even if the product or particular lot number are not listed since some manufacturers are recalling only certain – but not all – of their hand sanitizer products."

In June, the FDA warned consumers not to use nine kinds of hand sanitizers because they may contain methanol, and added to the list in early July, expanding it multiple times that month.

The FDA has said it has taken steps to prevent the products from entering the country by placing them on an import alert. Most of the products appear to have been produced in Mexico and, according to the alert, should be avoided because they pose a health risk.

Methanol is used industrially as a solvent, pesticide and alternative fuel source, according to the Centers for Disease Control and Prevention. Exposure to it can cause nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system and death.

Hand sanitizer has been a popular product to combat the coronavirus since February, and many new types have entered the market after shortages of brands including Purell.

“We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol,"  FDA Commissioner Stephen M. Hahn said in a statement. "Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated.”

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Avoid these hand sanitizers

The FDA says the products are on its list for several reasons. They might contain methanol or may be labeled that they contain methanol. They also could have microbial contamination or be subpotent, which means “it has less than the required amount of ethyl alcohol, isopropyl alcohol or benzalkonium chloride.”

Others were put on the list because they were “purportedly made at the same facility as products that have been tested by FDA and found to contain methanol.”

Find more information, including the product code where available, on the FDA website.

  • Grupo Insoma S.A.P.I's Hand sanitizer Gel Unscented 70% Alcohol
  • Mystic International's Mystic Shield Protection hand sanitizer
  • Soluciones Cosmeticas's Bersih Hand Sanitizer Gel Fragrance Free
  • Soluciones Cosmeticas's Bersih Antiseptic Alcohol 70% Topical Solution hand sanitizer
  • Soluciones Cosmeticas's Purity Advanced Hand Sanitizer
  • Tropicosmeticos's Britz Hand Sanitizer Ethyl Alcohol 70%    
  • Tropicosmeticos's Parabola Hand Sanitizer  
  • Tropicosmeticos's Urbane Bath and Body Hand Sanitizer    
  • Tropicosmeticos's Cleaner Hand Sanitizer Rinse Free 70%    
  • Tropicosmeticos's Handzer Hand Sanitizer Rinse Free
  • Tropicosmeticos's Kleanz Antibacterial Hand Sanitizer Advanced
  • Tropicosmeticos's Be Safe Hand Sanitizer
  • Tropicosmeticos's Wave Hand Sanitizer Gel
  • Eskbiochem's CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol
  • Eskbiochem's Lavar 70 Gel Hand Sanitizer
  • Eskbiochem's All-Clean Hand Sanitizer
  • Eskbiochem's Esk Biochem Hand Sanitizer
  • Eskbiochem's The Good Gel Antibacterial Gel Hand Sanitizer
  • Eskbiochem's CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol
  • Eskbiochem's CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol
  • Eskbiochem's Saniderm Advanced Hand Sanitizer
  • AAA Cosmetica's bio aaa Advance Hand Sanitizer 
  • AAA Cosmetica's LumiSkin Advance Hand Sanitizer 4 oz
  • AAA Cosmetica's LumiSkin Advance Hand Sanitizer 16 oz
  • AAA Cosmetica's QualitaMed Hand Sanitizer  
  • 4E Global SAPI's Blumen Clear Advanced Hand Sanitizer with 70% Alcohol
  • 4E Global SAPI's Blumen Advanced Instant Hand Sanitizer Clear Ethyl Alcohol 70%
  • 4E Global SAPI's BLUMEN Advanced Instant Hand Sanitizer Clear
  • 4E Global SAPI's BLUMEN Advanced Instant Hand Sanitizer Clear
  • 4E Global SAPI's KLAR AND DANVER Instant Hand Sanitizer
  • 4E Global SAPI's MODESA Instant Hand Sanitizer Moisturizers and Vitamin E
  • 4E Global SAPI's BLUMEN Advanced Hand Sanitizer
  • 4E Global SAPI's BLUMEN Advanced Hand Sanitizer
  • 4E Global SAPI's BLUMEN Advanced Hand Sanitizer Aloe
  • 4E Global SAPI's BLUMEN Advanced Instant Hand Sanitizer Lavender
  • 4E Global SAPI's BLUMEN Clear Advanced Hand Sanitizer
  • 4E Global SAPI's BLUMEN Clear Advanced Hand Sanitizer
  • 4E Global SAPI's BLUMEN Clear LEAR Advanced Hand Sanitizer
  • 4E Global SAPI's BLUMEN Clear LEAR Advanced Hand Sanitizer
  • 4E Global SAPI's The Honeykeeper Hand Sanitizer
  • 4E Global SAPI's BLUMEN Advanced Hand Sanitizer Clear
  • 4E Global SAPI's BLUMEN Clear Advanced Instant Hand Sanitizer
  • 4E Global SAPI's BLUMEN Clear Advanced Instant Hand Sanitizer Aloe
  • 4E Global SAPI's BLUMEN Clear Advanced Instant Hand Sanitizer Lavender
  • 4E Global SAPI's BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol
  • 4E Global SAPI's BLUMEN Aloe Advanced Hand Sanitizer, with 70 Alcohol
  • 4E Global SAPI's Blumen Advanced Hand Sanitizer Lavender, with 70% alcohol
  • 4E Global SAPI's Blumen Advanced Hand Sanitizer Aloe, with 70% alcohol
  • 4E Global SAPI's Blumen Antibacterial Fresh Citrus Hand Sanitizer
  • 4E Global SAPI's Blumen Hand Sanitizer Fresh Citrus
  • 4E Global SAPI's KLAR and DANVER Instant Hand Sanitizer
  • 4E Global SAPI's Hello Kitty Hand Sanitizer
  • 4E Global SAPI's Assured Instant Hand Sanitizer (Vitamin E and Aloe)
  • 4E Global SAPI's Assured Instant Hand Sanitizer (Aloe and Moisturizers)
  • 4E Global SAPI's Assured Instant Hand Sanitizer Vitamin E and Aloe
  • 4E Global SAPI's Assured Instant Hand Sanitizer Aloe and Moisturizers
  • 4E Global SAPI's BLUMEN Instant Hand Sanitizer Fragrance Free
  • 4E Global SAPI's BLUMEN Instant Hand Sanitizer Aloe Vera
  • 4E Global SAPI's Assured Aloe
  • DDI Multinacional's Earths Amenities Instant Unscented Hand Sanitizer with Aloe Vera Advanced
  • DDI Multinacional's Hand Sanitizer Agavespa Skincare
  • DDI Multinacional's Vidanos Easy Cleaning Rentals Hand Sanitizer Agavespa Skincare
  • Limpo Quimicos's Andy’s Best
  • Limpo Quimicos's Andy’s
  • Limpo Quimicos's NeoNatural
  • Limpo Quimicos's Plus Advanced
  • Liqesa Exportacion or Liq-E-S.A.'s Optimus Lubricants Instant Hand Sanitizer
  • Maquiladora Miniara's Selecto Hand Sanitizer
  • Maquiladora Miniara,'s Shine and Clean Hand Sanitizer
  • Soluciones Cosmeticas's Hand Sanitizer Gel Alcohol 70%
  • Yara Elena De La Garza Perez Nieto's DAESI Hand Sanitizer  
  • Real Clean Distribuciones's Born Basic. Anti-Bac Hand Sanitizer 70% alcohol
  • Real Clean Distribuciones's Born Basic. Anti-Bac Hand Sanitizer 65% Alcohol
  • Real Clean Distribuciones's Scent Theory – Keep It Clean – Pure Clean Anti-bacterial Hand Sanitizer
  • Real Clean Distribuciones's Cavalry
  • Real Clean Distribuciones's ENLIVEN Hand Sanitizing Gel
  • Real Clean Distribuciones's Lux Eoi Hand Sanitizing Gel
  • Real Clean Distribuciones's Scent Theory – Keep It Clean – Pure Clean Anti-bacterial Hand Sanitizer
  • MXL Comercial's Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol
  • MXL Comercial's Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol Rinse Free Hand Rub
  • Liqesa Exportacion or Liq-E-S.A.'s Optimus Instant Hand Sanitizer
  • Liqesa Exportacion or Liq-E-S.A.'s Optimus Instant Hand Sanitizer
  • Laboratorios Jaloma's Jaloma Antiseptic Hand Sanitizer Ethyl Alcohol 62% with Vitamin E
  • Leiper’s Fork Distillery's Leiper’s Fork Distillery Bulk Disinfectant per 5 gallon and Leiper’s Fork Distillery 16 oz bottle
  • Broncolin's Herbacil Antiseptic Hand Sanitizer 70% Alcohol
  • Broncolin's Herbacil Antiseptic Hand Sanitizer 70% Alcohol
  • Broncolin's Herbacil Antiseptic Hand Sanitizer 70% Alcohol
  • Albek de Mexico's NEXT Hand Sanitizer
  • Albek de Mexico's NuuxSan Instant Antibacterial Hand Sanitizer
  • Albek de Mexico's NuuxSan Instant Hand Sanitizer
  • Albek de Mexico's Assured Instant Antiseptic Hand Sanitizer with Aloe and Moisturizers
  • Albek de Mexico's Assured Instant Antiseptic Hand Sanitizer with Vitamin E and Aloe
  • Albek de Mexico's Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Aloe Vera
  • Albek de Mexico's Modesa Instant Antiseptic Hand Sanitizer with Moisturizers and Vitamin E
  • Healthy Foods & Nutrition Lab de Mexico's Medicare Alcohol Antiseptic Topical Solution
  • Incredible Products's GelBact Hand Sanitizer
  • Incredible Products's Hand Sanitizer
  • Incredible Products's TriCleanz
  • JG Atlas Comercios's Sayab Antisepctic Hand Sanitizer 100
  • Tritanium Labs USA's TriCleanz Tritanium Labs Hand Sanitizer
  • DEPQ Internacional's dgreen Advanced Sanitizer Alcohol Free
  • DEPQ Internacional's dgreen Advanced Hand Sanitizer Antibacterial Gel
  • DEPQ Internacional's Hand Sanitizer
  • DEPQ Internacional's Hand Sanitizer Gel
  • DEPQ Internacional's Clean Humans Hand Sanitizer
  • Notarika's Greenfrog Hand Sanitizing wipes
  • Notarika's Greenfrog Hand Sanitizer
  • Quimica Magna de Mexico's Datsen Hand Sanitizer
  • Quimica Magna de Mexico's Alcohol Antiseptic 62% Hand Sanitizer
  • Quimica Magna de Mexico's Bernal Hand Sanitizer
  • Quimica Magna de Mexico's Alcohol Antiseptic 65% Hand Sanitizer; Alcohol Antiseptic 70% Hand Sanitizer
  • Roque Plast's Command Gel AntiBac Instant hand sanitizer
  • Spartan Chemical Co Inc.'s Lite ’n Foamy Lemon Blossom Hand Sanitizer
  • Spartan Chemical Co Inc.'s foamyiQ Lemon Blossom Hand Sanitizer
  • Asiaticon's V-KLEAN Hand Sanitizer Gel
  • Asiaticon's V-KLEAN Hand Sanitizer Gel
  • Asiaticon's V-KLEAN Hand Sanitizer Gel
  • Asiaticon's Derma70 Hand Sanitizer
  • Asiaticon's V-KLEAN
  • Asiaticon's Medically Minded Hand Sanitizer Gel
  • Asiaticon's Protz Real Protection Antibacterial Hand Sanitizer
  • Botanicals Internacional's All Clear Hand Sanitizer Fragrance Free
  • Botanicals Internacional's Alcohol Antiseptic 80% topical solution hand sanitizer
  • Botanicals Internacional's Inatek Hand Sanitizer Non-Sterile Solution
  • Botanicals Internacional's Total Pure Alcohol Based Hand Sanitizer Gel
  • Botanicals Internacional's 70% Alcohol Gel Hand Sanitizer
  • Botanicals Internacional's ResQue 1st Instant Hand Sanitizer
  • Botanicals Internacional's 70% Alcohol Gel Hand Sanitizer
  • Botanicals Internacional's 70% Alcohol Gel Hand Sanitizer
  • Estrategia Hospitalaria's OZO Hand Sanitizer, Luxury Formula
  • Grupo Insoma S.A.P.I's Hand sanitizer
  • Ismar Soluciones Dinámicas's OZO Hand Sanitizer
  • Noticias Mexico Hoy Grupo Multimedia's Medical Mary Clean Hand Sanitizer
  • Noticias Mexico Hoy Grupo Multimedia's AMX Instant Hand Sanitizer
  • Asiaticon's V-KLEAN Hand Sanitizer Gel 
  • Grupo Yacana Mexico SAS De Cv's Yacana Alcohol Antiseptic 70% Topical Solution
  • Grupo Yacana Mexico SAS De Cv's Yacana Isopropyl Alcohol Antiseptic 70% Topical Solution
  • Grupo Yacana Mexico SAS De Cv's Yacana Clase Mundial Isopropyl Alcohol Antiseptic 70% Topical Solution or Gel
  • Ignacio Reyes Gonzalez's Medically Minded Hand Sanitizer Gel Antimicrobial Formula
  • Ignacio Reyes Gonzalez's Alcohol Antiseptic 70% Solution or 80% Solution
  • Ismar Soluciones Dinámicas S de RL de CV (Mexico)'s OZO Ozone Hand sanitizer Gel
  • Ismar Soluciones Dinámicas S de RL de CV (Mexico)'s Goldsquare Hand Sanitizer
  • Ismar Soluciones Dinámicas S de RL de CV (Mexico)'s Medi Science Laboratories Germ Killa 70% Alcohol Hand Gel
  • Harmonic Nature S de RL de MI (Mexico)'s Alcohol Antiseptic 75% Topical Solution Hand Sanitizer
  • Grupo Plast Y Kosas Sa De CV (Mexico)'s M Hand Sanitizer Alcohol Antiseptic topical solution 80% Topical Solution Hand Sanitizer
  • Grupo Plast Y Kosas Sa De CV's (Mexico)'s Jalisco Paper Inc Restaurant Supplies Hand Sanitizer
  • Grupo Plast Y Kosas Sa De CV's (Mexico)'s O.K. Pharmacy Hand Sanitizer
  • Grupo Plast Y Kosas Sa De CV's (Mexico)'s Hand Sanitizer Alcohol Antiseptic topical solution 80%
  • Open Book Extracts (North Carolina)'s Always Be Clean Hand Sanitizer
  • Open Book Extracts (North Carolina)'s Just Hand Sanitizer Single Use Packs
  • Plastico Las Palmas SA de CV (Mexico)'s BV BYE Virus 99
  • Plastico Las Palmas SA de CV (Mexico)'s In Good Hands Hand Sanitizer Gel
  • Santa Cruz Biotechnology (Texas)'s UltraCruz Hand Sanitizing Gel Antimicrobial
  • SG24 LLC (Georgia)'s SkinGuard24 All-Day Hand Sanitizer
  • Volu-Sol, Inc. (Utah)'s Volu-Sol Handrub Sanitizing Solution
  • Yangzhou Olande Cosmetic Co. Ltd (China)'s Leafree Instant Hand Sanitizer

Recalled hand sanitizers

The following products have been recalled or recommended for recall as of Aug. 14:

  • ITECH 361's All Clean Hand Sanitizer, Moisturizer and Disinfectant: UPC code 628055370130.
  • Transliquid Technologies' Mystic Shield Protection hand sanitizer: NDC numbers include 75477-435-02, 75477-435-10, 75477-435-12, 75477-435-25, 75477-435-50 and 75477-534-10.
  • Saniderm Advanced Hand Sanitizer, 1-liter bottles: Two distributors. The UVT hand sanitizer is labeled with lot number 0530 and an expiration date of 04/2022 and the Saniderm Products hand sanitizer is labeled with lot number 53131626 and “Manufactured on April/1/20.”
  • 4e Brands North America's Blumen brand is "voluntarily recalling all lots of Hand Sanitizer brands to the consumer level." This is an expansion of an earlier recall.
  • Real Clean Distribuciones is voluntarily recalling all lots it manufactured within expiry of the following brand names of hand sanitizers: "Born Basic ANTI-BAC HAND SANITIZER, Scent Theory KEEP CLEAN Moisturizing Hand Sanitizer, Scent Theory KEEP IT CLEAN Moisturizing Hand Sanitizer and Lux Eoi Hand Sanitizing Gel to the consumer level."
  • LIQ-E S.A. de C.V. is voluntarily recalling all lots and all bottle sizes of "The OPTIMUS Instant Hand Sanitizer" manufactured between April 27 and May 8.
  • Resource Recovery & Trading LLC is "voluntarily recalling all the lots manufactured by MXL Comercial S.A. de C.V." with the following information: “Hand Sanitizer 70% Ethyl Alcohol Disinfectant Gel, packaged in 6.7 FL Oz. (200 ml) bottles, UPC 650240026020 and Hand Sanitizer Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) liter plastic containers, UPC 37710600013 to the consumer level.”
  • Broncolin is "voluntarily recalling all lots of Herbacil Antiseptic Hand Sanitizer 70% Alcohol to the consumer level." The hand sanitizer comes in four different sizes, according to the recall notice.
  • Albek de Mexico is "voluntarily recalling all lots and all brands of hand sanitizer currently in US distribution to the consumer level."
  • Roque Plast is "voluntarily recalling lots 200371-12, 200371OH-05, 170420OH-06, 170420OH-8 manufactured by Roque Plast S.A. de C.V. of Command Brands Gel AntiBac Instant Hand Sanitizer to the consumer level."
  • Incredible Products is voluntarily recalling one lot of “GELBAC T ANTIBACTERIAL HANDGEL, packaged in 1 liter /33.8 oz plastic bottles and 125ml/4.2 oz plastic bottles of to the consumer level” due to the potential presence of methanol.  
  • Grupo Yacana Mexico SAS De Cv's Yacana Alcohol Antiseptic 70% Topical Solution
  • Grupo Yacana Mexico SAS De Cv's Yacana Isopropyl Alcohol Antiseptic 70% Topical Solution
  • Grupo Yacana Mexico SAS De Cv's Yacana Clase Mundial Isopropyl Alcohol Antiseptic 70% Topical Solution or Gel
  • Harmonic Nature S de RL de MI (Mexico)'s Alcohol Antiseptic 75% Topical Solution Hand Sanitizer
  • Open Book Extracts (North Carolina)'s Always Be Clean Hand Sanitizer
  • Open Book Extracts (North Carolina)'s Just Hand Sanitizer Single Use Packs
  • Santa Cruz Biotechnology (Texas)'s UltraCruz Hand Sanitizing Gel Antimicrobial
  • SG24 LLC (Georgia)'s SkinGuard24 All-Day Hand Sanitizer
  • Volu-Sol, Inc. (Utah)'s Volu-Sol Handrub Sanitizing Solution

Contributing: Nathan Bomey

Follow USA TODAY reporter Kelly Tyko on Twitter: @KellyTyko

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Sours: https://www.usatoday.com/story/money/2020/08/04/hand-sanitizer-recalls-methanol-risk-fda-warning-coronavirus/5581182002/

Now discussing:

Interpretation of Compliance Requirements for Wet Wipes in China

China,Biocide,Compliance Requirements,Wet Wipes,Classification

Wet wipes are common in life and have huge market potential. When the companies produce or sell wet wipes in China, they often fail to do compliance sales as they are not familiar with relevant regulations and standards, resulting in a notice of criticism or administrative penalty by relevant quality control department and affecting corporate image and reputation. Chemical Inspection and Regulation Service Limited (CIRS) will interpret relevant regulations and standards for wet wipes in detail, to remind the companies of some precautions.

1.Classification of wet wipes

Wet wipes can be roughly classified into general purpose wet wipes, hygiene wet wipes and disinfecting wet wipes based on intended use. General purpose wet wipes refer to general cleaning wipes without bactericidal effects which can be applied on human body, kitchen utensils and toilet utensils; hygiene wet wipes refer to cleaning and bactericidal wipes applied on hand, skin, mucous membrane or surface of ordinary objects; disinfecting wet wipes refer to disinfectant wipes applied on hand, skin, mucous membrane or surface of ordinary object and medical device. General purpose wet wipes and hygiene wet wipes are disposable sanitary products, and disinfecting wipes may be treated as carrier disinfectants in future according to the newly issued draft standard Hygienic Requirements for Carrier Disinfectant. General purpose wet wipes and hygiene wet wipes do not have to do notifications and only need to be tested before being marketed. However, the disinfecting wet wipes may need to complete the safety evaluation report and to do notifications in local health departments before being put to the market, and can be marketed after approval.

2 Compliance requirements for wet wipes in China

Compliance requirements of wet wipes in China are divided into two parts: first of all, the label or instruction shall be compiled in accordance with related provisions, and not include noncompliance contents; secondly, in aspect of hygienic indicator, the product shall be tested accordingly, and the test result shall meet corresponding standards. Products satisfying the above requirements can be put into market.

2.1 Compliance requirements on labels and instructions

Wet wipes are disinfection products, so the labels and instructions shall be compiled in accordance with the Specification on Management of Label and Instruction for Disinfection Product. The label and instruction shall not have any false or exaggerated contents, nor involve any disease treatment functions and effects, whether expressed or implied. Besides, the label and instruction shall include the following contents:

(1) Product name

(2) General purpose wet wipes shall be marked with name of main raw materials. Hygiene wet wipes and disinfecting wet wipes shall be marked with active germicidal ingredients and their contents

(3) Manufacturer (name, address, Tel. and zip code)

(4) Hygienic license No. of the manufacturer (except the imported wipes)

(5) Country of origin or area of origin (except the domestic wipes)

(6) Date of production and validity period/batch number and expiration time

(7) Disinfection grade sanitary products shall be marked with the word "disinfection grade"

(8) Hygiene wet wipes and disinfecting wet wipes shall also be marked with active germicidal ingredients and their contents, use methods, scope of application and precautions

(9) The disinfecting wet wipes shall also be marked with the formulation type, specification, category of microorganisms killed and executing standard

(10) Disinfecting wet wipes applied on mucous membrane shall also be marked with "only for diagnosis and treatment by medical and health institution"

Among them, the product name shall comply with the Regulations on Naming of Health-related Products issued by the Ministry of Health, and include trade name (or brand name), common name and property name. “##®” shall be marked if the trademark has been registered. "##TM" shall be marked if the trademark is applied for registration. The remaining products shall be marked with "## 牌(brand)". It is not allowed to label antibacterial and bactericidal effects on general purpose wet wipes. It is not allowed to include the words "antibacterial effect" in name of hygiene wipes. Hygiene wet wipes and disinfecting wet wipes shall not be labeled with contents such as medication, quick acting, high efficiency, no toxicity, prevention of sex transmitted disease, disease treatment, alleviation of symptoms, anti-inflammatory effect, scope of application and object not based on tests, dosage and method, antibacterial effect and category of microorganism killed and expiration date not based on test, as well as being applied on feet, eyes, nails, axilla, scalp, hair, nasal mucosa, anorectal part and other specific parts.

Besides, plants or other substances which can't be marked with main active ingredients shall be labeled with name of main raw material (Latin name for plants) and amount of raw materials added in unit volume. It is not allowed to add and label antibiotic, hormone, metronidazole, adrenocortical hormone and other prohibited ingredients in wet wipes.

2.2 Compliance requirements on hygienic indicator

2.2.1 Hygienic indicator for general purpose wet wipes

General purpose wet wipes are disposable sanitary products and should meet the requirements of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products and GB/T 27728-2011 Wet Wipes and relevant standards. It mainly includes the following test items: total number of bacterial colonies, coliform bacteria, pathogenic purulent bacteria (pseudomonas aeruginosa, staphylococcus aureus and hemolytic streptococcus), total number of fungal colonies, liquid content, transverse tensile strength, packing and sealing performance, pH value and migratable fluorescent whitening agent, etc.

2.2.2 Hygienic indicator for hygiene wet wipes

Hygienic wet wipes refer to wipes using non-woven fabrics, textile, wood pulp composite fabrics and wood pulp papers as carriers, added with appropriate amount of production water, disinfectant solution and other raw materials, and cleaning and sterilizing the objects (such as the hand, skin, mucous membrane and surface of ordinary objects). The hygienic wet wipes shall comply with not only the requirements of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, but also relevant requirements of WS 575-2017 Hygienic Wipes. Specific requirements are as follows:

Table 1 Requirements on the Active Ingredient Limit of Hygiene Wipes Applied on Hand, Skin and Mucous Membrane

Use Object

Chlorhexidine Gluconate, Chlorhexidine Acetate (g/L)

2,4,4'-trichloro-2'-hydroxydiphenylether(triclosan) (g/L)

Benzalkonium Bromide, Benzalkonium Chloride (g/L)

Other restricted substances required by the state

Hand, skin

≤45.0

≤20.0

≤5.0

Compliant

Mucous membrane

≤5.0

≤3.5

≤2.0

Compliant

Table 2 Requirements for Microbiological Index

Product type

Total number of bacterial colonies (CFU/g)

Coliform bacteria

Pathogenic purulent bacteria

Total number of fungal colonies (CFU/g)

Hygienic wet wipes

≤20.0

Non-detectable

Non-detectable

Non-detectable

Table 3 Requirement for Microorganism Killing Index

Product type

Escherichia coli

Staphylococcus aureus

Monilia albican a

Other microorganisms b

Hygienic wet wipes

≥90

≥90

≥90

≥90

a: This test shall be conducted if it is labeled as killing fungi

b: The corresponding microorganism killing test shall be conducted if it is labeled as killing other microorganisms

Table 4 Requirement of Toxicological Safety Indexes

Object

Multiple intact skin irritation test

Vaginal mucosa irritation test a

Acute eye irritation test b

Skin sensitization test c

Hand, skin

Non-irritation or slight irritation

-

-

Non or extremely slight irritation

Mucous membrane

Non-irritation or slight irritation

Non-irritation or extremely slight irritation

Non-irritation or slight irritation

Non or extremely slight irritation

Note: "-" represents that the test is not needed.

a. For hygiene wet wipes for the vaginal mucosa, a vaginal mucosal irritation test shall be conducted when occasionally or in intervals of several days of use; multiple vaginal mucosal irritation tests shall be conducted in case of continuous use.

b Hygienic wipes for use on mucous membranes other than the vaginal mucosa.

c Hygienic wipes for babies.

Besides, the WS 575-2017 has specific requirements on pH value, stability, metal corrosion and other indexes of the hygiene wet wipes. It is suggested that the companies involving hygiene wet wipes shall learn more about this standard.

2.2.3 Compliance requirements for disinfecting wet wipes

Previously, as the disinfecting wet wipes were not included in the catalogue of disinfection products, there were no regulations and standards for disinfecting wipes, and the regulatory authorities were uncertain, the domestic supervision on disinfecting wipes has been in a mess. However, the draft for comments of Hygienic Requirements for Carrier Disinfectant issued by China Health Inspection Association Group Standards Committee recently may change this situation. The draft for comments clearly states that the disinfecting wipes are carrier disinfectants and can be applied on hand, skin, mucous membrane, surface of ordinary object, medical devices and medical supplies and environmental surface. Based on the use object and Technical Requirements for the Hygiene and Safety Evaluation of Disinfectant Products, the disinfecting wipes belong to Class I and Class II disinfectant product. Before putting to the market for the first time, the responsible entity shall complete the safety evaluation report and notification in the provincial health department. Then It can be marketed after approval. The above-mentioned group standard provides a basis for market regulation and compliance requirements of disinfecting wet wipes.

The draft for comments of Hygienic Requirements for Carrier Disinfectant has the same requirements on active ingredient content and toxicology as hygiene wet wipes, but has higher requirements on microbiological and microorganism killing indexes, as follows:

Table 1 Requirements for Microbiological Index

Product type

Total number of bacterial colonies (CFU/g)

Coliform bacteria

Pathogenic purulent bacteria

Total number of fungal colonies (CFU/g)

Disinfecting wet wipe

≤10.0

Non-detectable

Non-detectable

Non-detectable

Table 2 Requirement for Microorganism Killing Index

Test strain

Disinfection object

Killing logarithm value

Hand

Skin

Mucous membrane

Surface of object

Surface of medical device

High level disinfection

Intermediate level disinfection

Low level disinfection

Escherichia coli 8099

+

-

-

+

-

-

-

≥5.00

Staphylococcus aureus ATCC6538

+

+

+

+

-

+

+

≥5.00

Pseudomonas aeruginosa ATCC15442

-

+

+

+a

-

+

+

≥5.00

Monilia albican ATCC10231

+

+

+

-

-

-

+

≥4.00

Mycobacterium chelonei ATCC93326

-

-

-

-

-

+

-

≥4.00

Bacillus subtilis var.niger ATCC9372

-

-

-

-

+

-

-

≥5.00

Vaccine strain of Virus. Polio types Ⅰ

-

-

-

-

-

+

-

≥4.00

Simulated field disinfection test

-

-

-

-

+

+

+

≥3.00

Field disinfection test

+

+

+

+

-

-

-

≥1.00

Note: "+" represents that the tests shall be done,and "-" represents that the test is not needed.

In addition to the above-mentioned three types of wet wipes, there is also makeup remover wipes, which belong to the category of cosmetics and must pass the notification in accordance with relevant regulations and standards of cosmetics before putting to the market.

After the wet wipes are sold in China, the quality and technical supervision department or the hygiene supervision department where the wet wipes are sold will conduct regular or irregular snap check on the wet wipes in its jurisdiction. There will be corresponding notice of criticism and punishment for nonconforming product, so relevant companies should fully understand relevant laws and regulations to ensure compliance of products.

If you have any needs or questions, please contact us at service@cirs-reach.com.

Sours: https://www.cirs-reach.com/news-and-articles/Interpretation-of-Compliance-Requirements-for-Wet-Wipes-in-China.html


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