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TESTOSTERONE CYPIONATE Recall D-1153-2022

Description: Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.

TESTOSTERONE CYPIONATE Recall D-1153-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1153-2022
Event ID90361
BrandTESTOSTERONE CYPIONATE
Generic NameTESTOSTERONE CYPIONATE
ManufacturerTESTOSTERONE CYPIONATE
Original Package?1
Active SubstanceTESTOSTERONE CYPIONATE
Drug RouteINTRAMUSCULAR
DistributionNationwide in the USA and Puerto Rico
Quantity97,450 vials
Recall ReasonCGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Drug ClassificationClass II
Drug Code Info20220629
Product NDC62756-015 62756-017 62756-016
Drug UPC0362756017405 0362756016408 0362756015401
Recall Initiation Date20220603
Report Date20220629
Classification Date20220621
Address2 Independence Way
Princeton, NJ 08540-6620
United States
Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
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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