HAND SANITIZER 1 mL/mL

Albek De Mexico S.A. De C.V.

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer 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.

SG24 LLC

Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug

Aroma Release Technologies Inc

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

Fisher Scientific Co., LLC

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

Valisa MFG LLC

Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol

Real Clean Distribuciones SA de CV

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.

Scentsational Soaps & Candles Inc

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Global Sanitizers LLC

Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

Global Sanitizers LLC

CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Lula Holdings L.L.C.

CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.