Hand Sanitizer recalled over manufacturing violations

Recall date

January 17, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Fisher Scientific Co., LLC recalls Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per ca…

Recall number

D-0163-2023

FDA classification

Class II

Brand / firm

Fisher Scientific Co., LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.