Drug product
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
D-0308-2021
Product summary
- Event
- Event 87498
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,146 bottles
- Official record key
drug-enforcement:D-0308-2021
Official wording
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Code information: Lot # 191659, exp. date 05/2021
Distribution pattern: Product was distributed nationwide
Derived failure modes
-
Potency or specification failure
Out-of-Specification