FDA recall D-0098-2023

Product

Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.

Reason for recall

Failed Impurities/Degradation specifications

Distribution

Product was distributed to one account in PA.

Key facts

Status

Terminated

Initiation date

2022-12-20

Report date

2023-01-18

Termination date

2023-03-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0098-2023