Drug product
Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg, caffeine 32.4 mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
D-0485-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,186,000 packets
- Official record key
drug-enforcement:D-0485-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9493, Exp. Date 02/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations