Alcohol 70 mL/100mL

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.

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.

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Valisa MFG LLC

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

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

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.

Bound Tree Medical, LLC

Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.

NingBo Huize Commodity Co.,Ltd.

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

CareFusion 213, LLC

Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.