PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 13, 2021 Initiated: November 23, 2020 #D-0185-2021

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.

Details

Recalling Firm
Ascend Laboratories LLC
Units Affected
20,232 bottles
Distribution
Distributed Nationwide in the USA
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Ascend Laboratories LLC. Units affected: 20,232 bottles.
Why was this product recalled? ▼
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 13, 2021. Severity: Moderate. Recall number: D-0185-2021.

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