Drug product
EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03
D-0491-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,694,200 packets
- Official record key
drug-enforcement:D-0491-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9599, Exp. Date 05/2022; AK9648, (L) 104, Exp. Date 06/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations