Drug recall D-0369-2024
Product
Febuxostat Tablets 80mg, 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 16714-060-01.
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots and codes
Lot #: DNE0894A, Exp 07/31/2025
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 7,488 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 4, 2024
Related products
- Febuxostat – drug information
- NDC 16714-059 Febuxostat · Febuxostat 40 mg/1 · NorthStar RxLLC
- NDC 16714-060 Febuxostat · Febuxostat 80 mg/1 · NorthStar RxLLC