Product Safety Recalls

Product Recall Tracker

TESTOSTERONE CYPIONATE Recall D-1154-2022

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-1154-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1154-2022
Event ID90391
BrandTESTOSTERONE CYPIONATE
Generic NameTESTOSTERONE CYPIONATE
ManufacturerTESTOSTERONE CYPIONATE
Original Package?1
Active SubstanceTESTOSTERONE CYPIONATE
Drug RouteINTRAMUSCULAR
DistributionNationwide within the United States
Quantity47,500 vials
Recall ReasonLack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Drug ClassificationClass II
Drug Code Info20220629
Product NDC62756-015 62756-017 62756-016
Drug UPC0362756017405 0362756016408 0362756015401
Recall Initiation Date20220610
Report Date20220629
Classification Date20220622
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
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.