Drug product
Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
D-0164-2023
Product summary
- Event
- Event 91427
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 106 bottles
- Official record key
drug-enforcement:D-0164-2023
Official wording
Reason: 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.
Code information: Lot Numbers: 202161, 202322, 202323, 202794, 202858, 203188, 203238, 203240, 203722 203723, 203724, 203725, 204852
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations