Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, ...
FDA Recall #D-0185-2021 — Class II — November 23, 2020
Product Description
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.
Recalling Firm
Ascend Laboratories LLC — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
20,232 bottles
Distribution
Distributed Nationwide in the USA
Code Information
Lot#: a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated