Drug product
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
D-0564-2023
Product summary
- Event
- Event 92248
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Pending
- Official record key
drug-enforcement:D-0564-2023
Official wording
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Code information: SKU 0901839 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