The Recall Desk
SevereFDA (Drugs)·D-0155-2022·Announced 2021-11-17

Talon Compounding Pharmacy Injectable Sterility Assurance Recall

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable medication containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility. The recall affects units distributed across 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. Lack of assurance of sterility in a compounded injectable product poses a serious risk of infection, which could result in hospitalization or significant medical complications. This meets the Severe threshold for FDA Class II recalls with high-risk potential for harm.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable compounded medication containing 200 mg testosterone cypionate, 0.5 mg anastrozole, and 1 mg dutasteride per mL in oil. The product is being recalled due to lack of assurance of sterility.

The product was manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247. The recall includes six lots with the following lot numbers and beyond-use dates: T1008192021:69 (BUD 02/15/2022), T1006142021:66 (BUD 12/11/2021), T1009092021:76 (BUD 03/08/2022), T1005142021:82 (BUD 11/10/2021), T1009212021:33 (BUD 03/20/2022), and T1006012021:01 (BUD 11/28/2021).

The medication was distributed to patients throughout the United States, including Washington, D.C. and Puerto Rico. Patients who have received this product should contact their healthcare provider for guidance. Consumers should not use the recalled product and should return it to their pharmacy or healthcare provider.

The recalled product

Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/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
Category
Drug — Compounded Injectable
Hazard
  • sterility-assurance
  • infection-risk
  • 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 (6)

  • Lot: T1008192021:69 BUD: 02/15/2022
  • T1006142021:66 BUD: 12/11/2021
  • T1009092021:76 BUD: 03/08/2022
  • T1005142021:82 BUD: 11/10/2021
  • T1009212021:33 BUD: 03/20/2022
  • T1006012021:01 BUD: 11/28/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category