Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
FDA Drug Recalls
24 recalls · Class II, newest first
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
Sildenafil Tablets USP 100 mg
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class II · Moderate risk
SYP Health Hand Sanitizer Alcohol Gel
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk
bio aaa Alcohol en Gel Antibacterial
CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
Class II · Moderate risk
Florance Morris ANTISEPTIC Hand Sanitizer
CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk
Command Brands GelAnti Bac Instant Hand Sanitizer
CGMP Deviation: Potential contamination with undeclared methanol.
Class II · Moderate risk
Herbacil
CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
LUX EOI Hand Sanitizing Gel
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Born Basic.
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
scent theory KEEP CLEAN Moisturizing Hand Sanitizer
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
scent theory KEEP IT CLEAN
CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Modesa instant HAND SANITIZER with moisturizers & vitamin E
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.
Class II · Moderate risk
ASSURED Instant Hand Sanitizer Aloe & Moisturizers
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.
Class II · Moderate risk
ASSURED Instant Hand Sanitizer Vitamin E and Aloe
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.
Class II · Moderate risk
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL 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.
Class II · Moderate risk
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL
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.
Class II · Moderate risk
blumen ADVANCED HAND SANITIZER
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.
Class II · Moderate risk
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70%…
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.
Class II · Moderate risk
Shine & Clean Hand Sanitizer gel
CGMP Deviations: Products manufactured at the same site were FDA testing found below the label claim for ethanol content and the presence of undeclared methanol.
Class II · Moderate risk
Saniderm ADVANCED HAND SANITIZER
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Class II · Moderate risk
Walker Hand Sanitizer
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Class II · Moderate risk
Walker Emulsions Hand Sanitizer
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.