Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, ...
FDA Recall #D-0284-2024 — Class II — January 5, 2024
Product Description
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
Reason for Recall
Subpotent Drug and Failed Impurities/Degradation Specifications
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
165,60 bottles
Distribution
Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Code Information
A200817 exp 1/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated