TESTOSTERONE CYPIONATE Recall D-1176-2022
Description: Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
TESTOSTERONE CYPIONATE Recall D-1176-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1176-2022 |
Event ID | 90412 |
Brand | TESTOSTERONE CYPIONATE |
Generic Name | TESTOSTERONE CYPIONATE |
Manufacturer | TESTOSTERONE CYPIONATE |
Original Package? | 1 |
Active Substance | TESTOSTERONE CYPIONATE |
Drug Route | INTRAMUSCULAR |
Distribution | nationwide. |
Quantity | 27 vials |
Recall Reason | CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery. |
Drug Classification | Class II |
Drug Code Info | 20220713 |
Product NDC | 62756-015 62756-017 62756-016 |
Drug UPC | 0362756017405 0362756016408 0362756015401 |
Recall Initiation Date | 20220603 |
Report Date | 20220713 |
Classification Date | 20220707 |
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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