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TESTOSTERONE CYPIONATE Recall D-0242-2021

Description: Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756-015-40

TESTOSTERONE CYPIONATE Recall D-0242-2021 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberD-0242-2021
Event ID87168
BrandTESTOSTERONE CYPIONATE
Generic NameTESTOSTERONE CYPIONATE
ManufacturerTESTOSTERONE CYPIONATE
Original Package?1
Active SubstanceTESTOSTERONE CYPIONATE
Drug RouteINTRAMUSCULAR
DistributionNationwide
Quantity36,275 cartons
Recall ReasonIncorrect Labeling: Incorrect lot number on secondary packaging
Drug ClassificationClass III
Drug Code Info20210203
Product NDC62756-015 62756-017 62756-016
Drug UPC0362756017405 0362756016408 0362756015401
Recall Initiation Date20210111
Report Date20210203
Termination Date20211102
Classification Date20210124
Address2 Independence Way
Princeton, NJ 08540-6620
United States
Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
Initial Notification Letter
Unique Ingredient IdentifierM0XW1UBI14
Drug Application NumberANDA201720
Structured Product Labeling (SPL ID)6c0ad3de-f509-4a28-be26-552c5c74a60d
Structured Product Labeling (SPL Set ID)3653a602-4551-4e6c-84a7-31861f5dc482
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