Injectable testosterone and dutasteride recalled for lack of sterility assurance
Talon Compounding Pharmacy is recalling 21 vials of injectable testosterone cypionate/dutasteride because the manufacturer cannot assure sterility of the product. The recall affects distribution across the United States, Washington D.C., and Puerto Rico.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 on injectable medications represents a significant risk of serious infection, which aligns with the Severe category for Class II recalls where serious harm is possible without reported illness yet being documented.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TEST CYPIONATE 200MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE across the United States, including Washington, D.C. and Puerto Rico. The product is a prescription-only injectable medication distributed by Talon Compounding Pharmacy in San Antonio, Texas.
The recall was initiated because the manufacturer cannot assure sterility of the product. Non-sterile injectable medications can introduce bacterial or fungal contamination that poses a serious health risk to patients.
Six lots are affected: T1006042021:53 (BUD 12/01/2021), T1008192021:83 (BUD 02/15/2022), T1005212021:52 (BUD 11/17/2021), T1009072021:35 (BUD 03/06/2022), T1007132021:61 (BUD 01/09/2022), and T1009142021:95 (BUD 03/13/2022). A total of 21 vials are affected.
Patients who have received this product should contact their healthcare provider immediately. Healthcare providers and pharmacists should stop dispensing the product and quarantine all remaining stock.
The recalled product
- Product
- TEST CYPIONATE 200MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- Affected units
- 21
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 (6)
- Lot: T1006042021:53 BUD: 12/01/2021
- T1008192021:83 BUD: 02/15/2022
- T1005212021:52 BUD: 11/17/2021
- T1009072021:35 BUD: 03/06/2022
- T1007132021:61 BUD: 01/09/2022
- T1009142021:95 BUD: 03/13/2022
Distribution
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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