Why it was recalled
Subpotent Drug and Failed Impurities/Degradation Specifications
Product description
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
Lot numbers, UPCs & expiration codes
A200817 exp 1/2024
Where it was sold
Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
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-0284-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 5, 2024
- FDA report date
- Feb 7, 2024
- Quantity
- 165,60 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0284-2024, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 93753
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- A200817 exp 1/2024
- Postal code
- 21202-6174
- Report date
- Feb 7, 2024
- Product type
- Drugs
- Recall number
- D-0284-2024
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 165,60 bottles
- Termination date
- Aug 27, 2024
- Reason for recall
- Subpotent Drug and Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
- Recall initiation date
- Jan 5, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 30, 2024