FDA (Drugs) recall action 86022

4e Brands North America, Llc recalled 10 products on 2020-10-07

The FDA (Drugs) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2020-10-07
Critical: 3
Units: 156,233,223

Why these products were recalled

Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.

CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–10 of 10

CriticalFDA (Drugs)··2020-10-07
Blumen Hand Sanitizer Recalled for Methanol and Low Ethanol Content
4e Brands North America is recalling Blumen Advanced Hand Sanitizer because testing found methanol contamination and ethanol levels below the labeled claim.
Product
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4, b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, Sa
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0 states
CriticalFDA (Drugs)··2020-10-07
Blumen Hand Sanitizer Recalled for Methanol and Low Alcohol Content
4e Brands North America is recalling Blumen hand sanitizer bottles and pumps found to contain methanol and less ethanol than labeled.
Product
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6 c) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 0236
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0 states
SevereFDA (Drugs)··2020-10-07
Modesa Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Modesa hand sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor manufacturing practices.
Product
Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7
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0 states
SevereFDA (Drugs)··2020-10-07
Blumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Blumen Advanced Hand Sanitizer due to manufacturing in a facility associated with methanol contamination.
Product
blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b) 7.5 fl. oz./221 ml bottle, UPC 8 14266 02362 4 b) 33.8 fl. oz./1L bottle, UPC 8 14266 02369 3, Distributed in USA and Canada By: 4e Brands No
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0 states
SevereFDA (Drugs)··2020-10-07
ASSURED Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling ASSURED Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination, representing poor CGMPs.
Product
ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10 fL oz / 296 ml bottle, UPC 6 39277 49069 8, Distributed by Geenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mex
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0 states
SevereFDA (Drugs)··2020-10-07
Assured Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Assured Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination, representing poor CGMP practices.
Product
ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in
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0 states
SevereFDA (Drugs)··2020-10-07
blumen Clear Advanced Hand Sanitizer Recalled for CGMP Deviations
4e Brands North America is recalling blumen Clear Advanced Hand Sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor Current Good Manufacturing Practices.
Product
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4 c) 15.2 fl oz (450 ml) bottle, UPC 8 14266 02392 1, d) 17 fl oz / 503 ml bottle with blue c
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0 states
CriticalFDA (Drugs)··2020-10-07
blumen Hand Sanitizer Recalled for Methanol Contamination and Low Ethanol
4e Brands North America is recalling blumen hand sanitizer bottles due to methanol contamination and ethanol levels below the labeled claim.
Product
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bottle, Distributed in USA and Canada by: 4e Brands 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico.
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0 states
SevereFDA (Drugs)··2020-10-07
Blumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Blumen Advanced Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination.
Product
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamer
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0 states
SevereFDA (Drugs)··2020-10-07
Blumen Aloe Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk
4e Brands North America is recalling Blumen Aloe Advanced Hand Sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor manufacturing practices.
Product
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. UPC 8 14266 02358 7
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0 states