Drug product
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.
D-0563-2023
Product summary
- Event
- Event 92248
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Pending.
- Official record key
drug-enforcement:D-0563-2023
Official wording
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Code information: SKUs a) 0901458; b) 0913023; c) 0999259 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