Drug product
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040
D-0481-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,351,660 packets
- Official record key
drug-enforcement:D-0481-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9453, Exp. Date 01/2022; AK9716, 07/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations