Drug product
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
D-0026-2022
Product summary
- Event
- Event 88809
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,976 bottles
- Official record key
drug-enforcement:D-0026-2022
Official wording
Reason: CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Code information: BT001594C
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations