PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 7, 2024 Initiated: January 5, 2024 #D-0284-2024

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

Details

Units Affected
165,60 bottles
Distribution
Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Location
Baltimore, MD

Frequently Asked Questions

What product was recalled?
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 165,60 bottles.
Why was this product recalled?
Subpotent Drug and Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on February 7, 2024. Severity: Moderate. Recall number: D-0284-2024.