FDA recall D-0359-2022

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 for recall

Failed impurities/degradation specifications

Distribution

USA nationwide.

Key facts

Status

Terminated

Initiation date

2021-12-21

Report date

2022-01-12

Termination date

2023-04-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0359-2022