Drug product
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
D-0525-2025
Product summary
- Event
- Event 97161
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1476 bottles
- Official record key
drug-enforcement:D-0525-2025
Official wording
Reason: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Code information: Lot: C2403017, Exp 12/31/2026
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign tablets