Drug product
PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
D-0492-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,336,600 packets
- Official record key
drug-enforcement:D-0492-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9433, Exp. Date 01/2022; AK9749, Exp. Date 08/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations