Why it was recalled
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # A200171, Exp 12/2023
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0100-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 12, 2022
- FDA report date
- Jan 18, 2023
- Quantity
- 16,056 30 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0100-2023, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 91295
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot # A200171, Exp 12/2023
- Postal code
- 21202-6174
- Report date
- Jan 18, 2023
- Product type
- Drugs
- Recall number
- D-0100-2023
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 16,056 30 count bottles
- Termination date
- Jan 31, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Dec 12, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 9, 2023