Drug product
Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
D-0469-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 297,050 packets
- Official record key
drug-enforcement:D-0469-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9602, Exp. Date 05/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations