Product Safety Recalls

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DIVALPROEX SODIUM Recall D-1291-2022

Description: Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.

DIVALPROEX SODIUM Recall D-1291-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1291-2022
Event ID90495
BrandDIVALPROEX SODIUM
Generic NameDIVALPROEX SODIUM
ManufacturerDIVALPROEX SODIUM
Original Package?1
Active SubstanceDIVALPROEX SODIUM
Drug RouteORAL
DistributionNationwide in the USA
Quantity9552 bottles
Recall ReasonFailed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Drug ClassificationClass II
Drug Code Info20220803
Product NDC62756-796 62756-797 62756-798
Drug UPC0362756796836 0362756798830
Recall Initiation Date20220627
Report Date20220803
Classification Date20220726
Address2 Independence Way
Princeton, NJ 08540-6620
United States
Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
Initial Notification Letter
Unique Ingredient Identifier644VL95AO6
Drug Application NumberANDA078597
Structured Product Labeling (SPL ID)aae406af-8556-4667-9ea6-6bc8b3ed2d51
Structured Product Labeling (SPL Set ID)64797788-fdcb-4d12-a1a4-743ad71bd17b
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