Drug product
Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.
D-0566-2023
Product summary
- Event
- Event 92248
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Pending
- Official record key
drug-enforcement:D-0566-2023
Official wording
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Code information: SKUs a) 0999841; b) 0916071 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