Drug product
CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
D-0511-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,019,000 packets
- Official record key
drug-enforcement:D-0511-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9475, Exp. Date 02/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations