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ZOLPIDEM TARTRATE Recall D-0272-2024

Description: Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, 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 47335-308-88.

ZOLPIDEM TARTRATE Recall D-0272-2024 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0272-2024
Event ID93820
BrandZOLPIDEM TARTRATE
Generic NameZOLPIDEM TARTRATE
ManufacturerZOLPIDEM TARTRATE
Original Package?1
Active SubstanceZOLPIDEM TARTRATE
Drug RouteORAL
DistributionNationwide in the USA
Quantity14,568 bottles
Recall ReasonCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Drug ClassificationClass II
Drug Code Info20240131
Product NDC47335-307 47335-308
Drug UPC0347335307887 0347335308884
Recall Initiation Date20240118
Report Date20240131
Classification Date20240125
Address2 Independence Way
Princeton, NJ 08540-6620
United States
Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
Initial Notification Letter
Unique Ingredient IdentifierWY6W63843K
Drug Application NumberANDA204170
Structured Product Labeling (SPL ID)4a5c474b-e752-4d01-be37-a66e7c9bf62e
Structured Product Labeling (SPL Set ID)0c64bc71-2e7f-4b15-a8e1-acb8de04395f
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