Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Product description
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.
Lot numbers, UPCs & expiration codes
Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025
Where it was sold
Nationwide
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-0368-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 4, 2024
- FDA report date
- Mar 20, 2024
- Quantity
- 47,520 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0368-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94142
- Address
- 2 Independence Way
- Code information
- Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025
- Postal code
- 08540-6620
- Report date
- Mar 20, 2024
- Product type
- Drugs
- Recall number
- D-0368-2024
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 47,520 bottles
- Reason for recall
- CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 4, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 8, 2024