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
Status | Terminated |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0242-2021 |
Event ID | 87168 |
Brand | TESTOSTERONE CYPIONATE |
Generic Name | TESTOSTERONE CYPIONATE |
Manufacturer | TESTOSTERONE CYPIONATE |
Original Package? | 1 |
Active Substance | TESTOSTERONE CYPIONATE |
Drug Route | INTRAMUSCULAR |
Distribution | Nationwide |
Quantity | 36,275 cartons |
Recall Reason | Incorrect Labeling: Incorrect lot number on secondary packaging |
Drug Classification | Class III |
Drug Code Info | 20210203 |
Product NDC | 62756-015 62756-017 62756-016 |
Drug UPC | 0362756017405 0362756016408 0362756015401 |
Recall Initiation Date | 20210111 |
Report Date | 20210203 |
Termination Date | 20211102 |
Classification Date | 20210124 |
Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
Initial Notification | Letter |
Unique Ingredient Identifier | M0XW1UBI14 |
Drug Application Number | ANDA201720 |
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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