Drug recall D-0264-2024
Product
Febuxostat Tablets 40mg, 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 47335-721-83.
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots and codes
Lot #s: DNE0866B Exp. 06/30/2025, DNE1045A, DNE1046B Exp. 08/31/2025
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 55,272 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 18, 2024
Related products
- Febuxostat – drug information
- NDC 47335-722 Febuxostat · Febuxostat 80 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-721 Febuxostat · Febuxostat 40 mg/1 · Sun Pharmaceutical Industries, Inc.