Recalls / Class II
Class IID-0100-2023
Product
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
- Brand name
- Rifampin
- Generic name
- Rifampin
- Active ingredient
- Rifampin
- Route
- Oral
- NDCs
- 68180-658, 68180-659
- FDA application
- ANDA090034
- Affected lot / code info
- Lot # A200171, Exp 12/2023
Why it was recalled
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 16,056 30 count bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2022-12-12
- FDA classified
- 2023-01-09
- Posted by FDA
- 2023-01-18
- Terminated
- 2024-01-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0100-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.