D-0164-2023 Class II Ongoing
FDA drug recall D-0164-2023 was initiated by Fisher Scientific Co., LLC on January 17, 2023 and is designated Class II. 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 th… The recall status is ongoing. Affected quantity: 106 bottles.
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
- 106 bottles
Product Description
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.
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: 202161, 202322, 202323, 202794, 202858, 203188, 203238, 203240, 203722 203723, 203724, 203725, 204852