Drug product
Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43
D-009-2014
Product summary
- Event
- Event 66218
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3867 bottles
- Official record key
drug-enforcement:D-009-2014
Official wording
Reason: Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Code information: Lot Number 59627; Expiration Date 02/2014
Distribution pattern: KY & TN
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.