Drug product
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50
D-0229-2022
Product summary
- Event
- Event 88982
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4104 bottles
- Official record key
drug-enforcement:D-0229-2022
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot 20140282, exp Dec 2021
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications