Recalls / Class II
Class IID-0368-2024
Product
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.
- Brand name
- Febuxostat
- Generic name
- Febuxostat
- Active ingredient
- Febuxostat
- Route
- Oral
- NDCs
- 16714-059, 16714-060
- FDA application
- ANDA205467
- Affected lot / code info
- Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025
Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- NorthStar RxLLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 47,520 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2024-03-04
- FDA classified
- 2024-03-08
- Posted by FDA
- 2024-03-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0368-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.