Drug product
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
D-0179-2021
Product summary
- Event
- Event 87032
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,524 bottles
- Official record key
drug-enforcement:D-0179-2021
Official wording
Reason: Failed Impurity/Degradation Specifications
Code information: 20141680, 20141681, 20141759
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications