FDA recall D-0360-2022

Product

Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Product was distributed to two direct accounts in MI and PA.

Key facts

Status

Terminated

Initiation date

2021-12-29

Report date

2022-01-12

Termination date

2022-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0360-2022