Drug recall D-0100-2023

Class II Terminated reported Jan 18, 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.

Lots and codes

Lot # A200171, Exp 12/2023

Recall details

Recalling firm
Lupin Pharmaceuticals Inc., Baltimore, MD
Quantity
16,056 30 count bottles
Distribution
Distributed Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
December 12, 2022
Terminated
January 31, 2024

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