Drug product
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
D-0565-2023
Product summary
- Event
- Event 92248
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0565-2023
Official wording
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Code information: SKUs 0902867 stored and distributed from DCs 07/28/2022 through 03/31/2023.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP deviation