FDA recall D-0283-2024

Lupin Pharmaceuticals Inc. · Class II · drug

Product

Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06

Reason for recall

Subpotent Drug and Failed Impurities/Degradation Specifications

Distribution

Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.

Key facts

Status
Terminated
Initiation date
2024-01-05
Report date
2024-02-07
Termination date
2024-08-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0283-2024