Drug product
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50
D-0359-2022
Product summary
- Event
- Event 89259
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42,698 bottles
- Official record key
drug-enforcement:D-0359-2022
Official wording
Reason: Failed impurities/degradation specifications
Code information: Lot #: 20140293, Exp Dec 2021; 20141525, 20141526, 20141527, Exp Mar 2022; 20143019, 20143020, 20143021, 20143022, Exp July 2022; 20144759, 20144760, 20144761, Exp Nov 22
Distribution pattern: USA nationwide.
Derived failure modes
-
Potency or specification failure
Failed impurities/degradation specifications