The Recall Desk
SevereFDA (Drugs)·D-0157-2022·Announced 2021-11-17

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.

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. 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
Manufacturer
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Category
Drug — Compounded Injectable
Hazard
  • sterility-assurance
  • injectable-contamination
  • microbial-hazard

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

Distribution scope not specified by the agency.

Related recalls

Same category