SUN PHARMACEUTICAL INDUSTRIES INC recalls Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industrie
Recalled January 31, 2024 · FDA recall D-0270-2024 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. · FDA Class II
Units
15,768 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
Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →