The Recall Desk
SevereFDA (Drugs)·D-0152-2022·Announced 2021-11-17

Talon Compounding Pharmacy Injectable Recalled for Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a testosterone cypionate injectable combination product due to lack of assurance of sterility. The product was distributed in 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 involving a sterile injectable drug product without assurance of sterility—a manufacturing control failure that poses significant risk of infection. Class II recalls involving injectable products warrant a Severe classification due to the potential for serious infection complications.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Test Cypionate 200mg/Anastrozole 0.5mg/Dutasteride 0.75mg/mL in Oil Injectable (Rx only) distributed throughout the United States, including Washington, D.C. and Puerto Rico.

The recall is issued due to lack of assurance of sterility. The affected lot is T1005192021:31 with a beyond-use date of 11/15/2021, manufactured by the pharmacy located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.

Consumers who have received this product should contact their pharmacy or healthcare provider regarding appropriate steps to take. Anyone with questions may reach Talon Compounding Pharmacy directly.

The recalled product

Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.75MG/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
  • 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: T1005192021:31 BUD: 11/15/2021

Distribution

Distribution scope not specified by the agency.