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

November 23, 2020

Class II

Product summary

Firm: Ascend Laboratories LLC
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
reason.potency_specification_failure · v1.0.0

Failed Impurity/Degradation Specifications