Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals ...
FDA Recall #D-0100-2023 — Class II — December 12, 2022
Product Description
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.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
16,056 30 count bottles
Distribution
Distributed Nationwide in the USA
Code Information
Lot # A200171, Exp 12/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated