Drug product
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054
D-0185-2021
Product summary
- Event
- Event 86850
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,232 bottles
- Official record key
drug-enforcement:D-0185-2021
Official wording
Reason: Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Code information: Lot#: a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specifications