Injectable Steroid Combination Product Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable product containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility. The recall affects lot T1009092021:19 distributed across the United States.
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: This is an FDA Class II recall of a sterile injectable compounded drug product lacking sterility assurance. Non-sterile injectable products pose a direct risk of serious infection and potential hospitalization, meeting the Severe severity criterion.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE (Rx only) distributed from their facility in San Antonio, Texas. The recall was initiated because the manufacturer could not provide assurance of sterility for the product.
The affected product is lot T1009092021:19 (BUD: 03/08/2022), distributed as 2 vials. Distribution included the United States, including Washington, D.C. and Puerto Rico.
Patients who have received this product should contact their healthcare provider. Healthcare providers who dispensed this product should contact the pharmacy for further instructions. Consumers should not use this product and should consult their healthcare provider immediately if they have received an injection from this lot.
The recalled product
- Product
- TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Hazard
- non-sterile-injectable
- sterility-assurance-failure
- infection-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 (1)
- Lot: T1009092021:19 BUD: 03/08/2022
Distribution
Distribution scope not specified by the agency.
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