SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Recalled January 31, 2024 · FDA recall D-0264-2024 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. · FDA Class II
Units
55,272 bottles
Sold at
Nationwide in the USA
Description
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
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.
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →