Testosterone Cypionate/Anastrozole Injectable Recalled for Sterility Assurance
Talon Compounding Pharmacy is recalling a testosterone cypionate and anastrozole injectable product because the manufacturer cannot assure sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Lack of sterility assurance in an injectable drug product represents a serious safety concern because non-sterile injectables can cause serious infections, and the source text indicates no reported illnesses yet, placing this within the Class II framework for potential for serious adverse health consequences.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 200mg/anastrozole 0.5mg/mL injectable in ethyl oleate. The recall affects 94 vials distributed in the United States, including Washington, D.C. and Puerto Rico.
The product is being recalled due to lack of assurance of sterility. Four lots are affected with the following expiration dates: Lot T1005122021 (BUD 11/08/2021), Lot T1006092021 (BUD 12/06/2021), Lot T1008242021 (BUD 02/20/2022), and Lot T1007192021 (BUD 01/15/2022).
Consumers who have received this product should contact their healthcare provider or pharmacist. The recalling firm is located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: T1005122021:40 BUD: 11/08/2021
- T1006092021:88 BUD: 12/06/2021
- T1008242021:26 BUD: 02/20/2022
- T1007192021:94 BUD: 01/15/2022
Distribution
Distribution scope not specified by the agency.
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