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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1154-2022 |
| Event ID | 90391 |
| Brand | TESTOSTERONE CYPIONATE |
| Generic Name | TESTOSTERONE CYPIONATE |
| Manufacturer | TESTOSTERONE CYPIONATE |
| Original Package? | 1 |
| Active Substance | TESTOSTERONE CYPIONATE |
| Drug Route | INTRAMUSCULAR |
| Distribution | Nationwide within the United States |
| Quantity | 47,500 vials |
| Recall Reason | Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion |
| Drug Classification | Class II |
| Drug Code Info | 20220629 |
| Product NDC | 62756-015 62756-017 62756-016 |
| Drug UPC | 0362756017405 0362756016408 0362756015401 |
| Recall Initiation Date | 20220610 |
| Report Date | 20220629 |
| Classification Date | 20220622 |
| 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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