Recall: D-0359-2022

Class II - Potentially Harmful

Class IIClassification

2021-12-21Initiated

TerminatedStatus

Ascend Laboratories, LLCFirm

Product

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

Failed impurities/degradation specifications

Distribution

USA nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.