FDA-Drug2024-02-07Class II

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

Lupin Pharmaceuticals Inc.
Hazard

Subpotent Drug and Failed Impurities/Degradation Specifications

Sold states
Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Affected count
165,60 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0284-2024

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