SUN PHARMACEUTICAL INDUSTRIES INC recalls Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceut
Recalled January 31, 2024 · FDA recall D-0271-2024 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. · FDA Class II
Units
1220 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
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 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 47335-307-88.
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →