Drug product
Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.
D-0265-2024
Product summary
- Event
- Event 93820
- Status
- Completed
- Classification
- Class II
- Quantity
- 19,992 bottles
- Official record key
drug-enforcement:D-0265-2024
Official wording
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Code information: Lot #s: DNE0867A Exp. 06/30/2025, DNE0894B Exp. 07/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
Microbial contamination