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TESTOSTERONE CYPIONATE Recall D-1190-2022

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

TESTOSTERONE CYPIONATE Recall D-1190-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1190-2022
Event ID90451
BrandTESTOSTERONE CYPIONATE
Generic NameTESTOSTERONE CYPIONATE
ManufacturerTESTOSTERONE CYPIONATE
Original Package?1
Active SubstanceTESTOSTERONE CYPIONATE
Drug RouteINTRAMUSCULAR
DistributionUSA Nationwide
Quantity50860 vials
Recall ReasoncGMP - Water leakage
Drug ClassificationClass II
Drug Code Info20220720
Product NDC62756-015 62756-017 62756-016
Drug UPC0362756017405 0362756016408 0362756015401
Recall Initiation Date20220621
Report Date20220720
Classification Date20220711
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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