Class II
Ongoing
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.
- Company
- Fisher Scientific Co., Llc
- Recall Initiated
- January 17, 2023
- Posted
- January 25, 2023
- Recall Number
- D-0163-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 1077 bottles, b) 52 cases
- Firm Location
- Fair Lawn, NJ, United States
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
Nationwide in the USA
Lot / Code Info
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
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