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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1153-2022 |
Event ID | 90361 |
Brand | TESTOSTERONE CYPIONATE |
Generic Name | TESTOSTERONE CYPIONATE |
Manufacturer | TESTOSTERONE CYPIONATE |
Original Package? | 1 |
Active Substance | TESTOSTERONE CYPIONATE |
Drug Route | INTRAMUSCULAR |
Distribution | Nationwide in the USA and Puerto Rico |
Quantity | 97,450 vials |
Recall Reason | CGMP 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 Classification | Class II |
Drug Code Info | 20220629 |
Product NDC | 62756-015 62756-017 62756-016 |
Drug UPC | 0362756017405 0362756016408 0362756015401 |
Recall Initiation Date | 20220603 |
Report Date | 20220629 |
Classification Date | 20220621 |
Address | 2 Independence Way Princeton, NJ 08540-6620 United States |
Recalling Firm | SUN PHARMACEUTICAL INDUSTRIES INC |
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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