PlainRecalls
FDA Drug Moderate Class II Terminated

Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50

Reported: January 12, 2022 Initiated: December 21, 2021 #D-0359-2022

Product Description

Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50

Reason for Recall

Failed impurities/degradation specifications

Details

Recalling Firm
Ascend Laboratories, LLC
Units Affected
42,698 bottles
Distribution
USA nationwide.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50. Recalled by Ascend Laboratories, LLC. Units affected: 42,698 bottles.
Why was this product recalled?
Failed impurities/degradation specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on January 12, 2022. Severity: Moderate. Recall number: D-0359-2022.