The Recall Desk
SevereFDA (Drugs)·D-0161-2022·Announced 2021-11-17

Talon Compounding Pharmacy Injectable Drug Lacks Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable drug containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility.

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 compounded drug—poses a significant risk of serious infection or adverse health outcomes if non-sterile product was administered to patients, meeting the Severe threshold for FDA Class II recalls involving injectable products and inherent risk of harm.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas, is recalling a compounded injectable product: TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 1MG/ML IN OIL. The product is prescription-only.

The recall was initiated due to lack of assurance of sterility. The affected product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Three lots are affected: Lot T1005172021:27 with a BUD of 11/13/2021; Lot T1007222021:42 with a BUD of 01/18/2022; and Lot T1009162021:45 with a BUD of 03/15/2022. A total of 19 vials are being recalled.

Patients who have received this product should consult their healthcare provider for further guidance. Healthcare providers should not dispense the affected lots and should contact customers who may have received the product.

The recalled product

Product
TEST CYPIONATE 200MG/ANASTROZOLE 1MG/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-failure
  • injectable-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 (3)

  • Lot: T1005172021:27 BUD: 11/13/2021
  • T1007222021:42 BUD: 01/18/2022
  • T1009162021:45 BUD: 03/15/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category