Drug product
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559
D-0261-2026
Product summary
- Event
- Event 98239
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unkown
- Official record key
drug-enforcement:D-0261-2026
Official wording
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Code information: All lots within expiry distributed by Gold Star Distribution.
Distribution pattern: US Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations