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FDARecalled Jan 31, 2024 · #D-0271-2024

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 Pharmaceutica...

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Classification: Class II Distribution: Nationwide in the USA

Product details

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.
Type
Drugs
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Model numbers
DNE0892A
UPCs