Injectable Compounded Hormone and Steroid Product Lacks Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable compounded drug product containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility. The product was distributed in the United States including 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. The hazard—lack of sterility assurance in an injectable drug product—poses a significant risk of serious infection or injury to patients who received the product. Although no illnesses or injuries are reported in the source text, the inherent risk profile of non-sterile injectables warrants a Severe classification under the rubric criterion for Class II recalls with significant injury/harm risk.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of a compounded injectable drug product containing TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 1.5MG/ML IN OIL (Lot T1009092021:66, beyond-use date 03/08/2022) because the product lacks assurance of sterility.
The product is a prescription-only injectable preparation that was distributed throughout the United States including Washington, D.C. and Puerto Rico as 2 vials.
Injectable drug products must meet strict sterility standards to ensure they are free from microbial contamination. Products lacking assurance of sterility pose a potential health risk to patients. Consumers who have received this product should consult their healthcare provider or pharmacist. Healthcare providers with questions about the recall should contact the recalling firm.
The recalled product
- Product
- TEST CYPIONATE 200MG/ANASTROZOLE 1.5MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- Affected units
- 2
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: T1009092021:66 BUD: 03/08/2022
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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