Drug recall D-0185-2021

Class II Terminated reported Jan 13, 2021

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

Reason for recall

Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.

Lots and codes

Lot#: a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022

Recall details

Recalling firm
Ascend Laboratories LLC, Parsippany, NJ
Quantity
20,232 bottles
Distribution
Distributed Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
November 23, 2020
Terminated
June 1, 2023

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