Home / Recalls / Fisher Scientific Co., LLC / D-0163-2023

D-0163-2023 Class II Ongoing

Recalled by Fisher Scientific Co., LLC — Fair Lawn, NJ

Recall Details

Product Type: Drugs
Report Date: January 25, 2023
Initiation Date: January 17, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 1077 bottles, b) 52 cases

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot Numbers: 202160, 202162, 202324, 202368, 202369, 202593, 202594, 202835, 202862, 202863, 202865, 202836, 202864, 203061, 203098, 203099, 203100, 203101, 203102, 203236, 203237, 203239, 203337, 203338, 203335, 203336