FDA recall D-0229-2022

Ascend Laboratories LLC · Class II · drug

Product

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

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2021-11-03
Report date
2021-11-17
Termination date
2022-12-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0229-2022