FDA recall D-0100-2023

Product

Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06

Reason for recall

Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-12-12

Report date

2023-01-18

Termination date

2024-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0100-2023