Recalls / Class II
Class IID-0283-2024
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
- Brand name
- Rifampin
- Generic name
- Rifampin
- Active ingredient
- Rifampin
- Route
- Oral
- NDCs
- 68180-658, 68180-659
- FDA application
- ANDA090034
- Affected lot / code info
- A200816 exp 1/2024 A201248 exp 3/2024
Why it was recalled
Subpotent Drug and Failed Impurities/Degradation Specifications
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
- 15,576 Bottles
- Distribution pattern
- Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
Timeline
- Recall initiated
- 2024-01-05
- FDA classified
- 2024-01-30
- Posted by FDA
- 2024-02-07
- Terminated
- 2024-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0283-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.