Drug 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.
D-0368-2024
Product summary
- Event
- Event 94142
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 47,520 bottles
- Official record key
drug-enforcement:D-0368-2024
Official wording
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Code information: Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
Microbial contamination