FDA-Drug2023-01-18Class II

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

Lupin Pharmaceuticals Inc.
Hazard

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

Sold states
Distributed Nationwide in the USA
Affected count
16,056 30 count bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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

Official notice

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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief