Drug product
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50
D-0470-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 174,852 bottles
- Official record key
drug-enforcement:D-0470-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: HY9042, Exp. Date 02/2022; HY9094, HY9112, Exp. Date 04/2022; HY9134, Exp. Date 05/2022; HY9267, Exp. Date 09/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations