Drug product
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
D-0647-2024
Product summary
- Event
- Event 95132
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 266 bottles
- Official record key
drug-enforcement:D-0647-2024
Official wording
Reason: Failed Impurities/Degradation Specifications - at 18-month Stability testing
Code information: Lot: B0223H, Exp: 5/31/2026; C3023H, Exp: 9/30/2026.
Distribution pattern: CA and NV
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications