Recall: D-0100-2023

Class II - Potentially Harmful

Class IIClassification

2022-12-12Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

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

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.