The Recall Desk
SevereFDA (Drugs)·D-0174-2022·Announced 2021-11-17

Testosterone Cypionate/Anastrozole Injectable Recalled for Lack of Sterility Assurance

Vita Pharmacy (Talon Compounding Pharmacy) is recalling two lots of testosterone cypionate 200mg/anastrozole 0.7mg/ml injectable solution due to lack of assurance of sterility. The product was distributed nationwide.

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 involving a compounded injectable pharmaceutical without assured sterility. Class II recalls, particularly those involving sterile injectables where microbial contamination poses risk of serious infection, meet the Severe threshold even without reported illness.

Plain-English summary

Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, is recalling testosterone cypionate 200mg/anastrozole 0.7mg/ml in oil injectable solution due to lack of assurance of sterility.

The affected product includes two vials with the following lot information: Lot T1007202021:25 with BUD (beyond use date) of 01/16/2022, and Lot T1009102021:46 with BUD of 03/09/2022. This is a prescription-only medication manufactured by Vita Pharmacy, LLC, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas.

The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients who have received this medication should contact their healthcare provider to determine whether they were affected and to discuss any appropriate follow-up care.

The recalled product

Product
TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.7MG/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-failure
  • microbial-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 (2)

  • Lot: T1007202021:25 BUD: 01/16/2022
  • T1009102021:46 BUD: 03/09/2022

Distribution

Distribution scope not specified by the agency.