PlainRecalls
FDA Drug Moderate Class II Terminated

Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50

Reported: November 17, 2021 Initiated: November 3, 2021 #D-0229-2022

Product Description

Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50

Reason for Recall

Failed Impurities/Degradation Specifications

Details

Recalling Firm
Ascend Laboratories LLC
Units Affected
4104 bottles
Distribution
Nationwide
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50. Recalled by Ascend Laboratories LLC. Units affected: 4104 bottles.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on November 17, 2021. Severity: Moderate. Recall number: D-0229-2022.