Injectable testosterone and dutasteride product recall for sterility assurance failure
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Test Cypionate 200mg/Dutasteride 1mg/ml Injectable due to lack of assurance of sterility. Affected lots include T1008312021:02 and T1007142021:62.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard is lack of assurance of sterility in an injectable product, which presents a risk of serious infection. No illnesses or injuries have been reported in the source text, making this a risk-of-harm scenario without reported adverse events, placing it at severity level 3 per the rubric.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Test Cypionate 200mg/Dutasteride 1mg/ml in oil injectable, Rx only. The product is being recalled due to lack of assurance of sterility.
The recalled product was distributed in the United States, including Washington, D.C. and Puerto Rico. The specific lots affected are: Lot T1008312021:02 with a Beyond Use Date (BUD) of 02/27/2022, and Lot T1007142021:62 with a BUD of 01/10/2022. The recalled product consists of 6 vials from Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.
Consumers who have received this product should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- TEST CYPIONATE 200MG/DUTASTERIDE 1MG/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
- sterility-assurance-failure
- infection-risk
- injectable-contamination
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 (2)
- Lot: T1008312021:02 BUD: 02/27/2022
- T1007142021:62 BUD: 01/10/2022
Distribution
Distribution scope not specified by the agency.
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