The Recall Desk
SevereFDA (Drugs)·D-0172-2022·Announced 2021-11-17

Testosterone Cypionate Anastrozole Injectable Recalled for Sterility Concerns

Talon Compounding Pharmacy is recalling a testosterone cypionate and anastrozole injectable product due to lack of assurance of sterility. The recall affects nine vials distributed across 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 of a sterile injectable pharmaceutical product. Lack of sterility assurance in injectable medications presents a significant risk of serious infection and harm; the product is a prescription injectable that directly enters the body, making any sterility failure a serious patient safety concern.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/Anastrozole 0.5mg/mL Injectable in sesame oil. The product is being recalled because the manufacturer cannot assure the sterility of the injectable medication.

The recalled product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. The affected lots are: Lot T1004132021:95 with expiration date 10/10/2021; Lot T1006162021:63 with expiration date 12/13/2021; and Lot T1004282021:19 with expiration date 10/25/2021. A total of 9 vials have been recalled.

Patients who have received this medication should consult with their healthcare provider immediately. Healthcare providers should quarantine remaining product and verify patient exposure.

The recalled product

Product
TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.5MG/ML INJ #2 IN SESAME 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
  • injectable-contamination
  • 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 (3)

  • Lot: T1004132021:95 BUD: 10/10/2021
  • T1006162021:63 BUD: 12/13/2021
  • T1004282021:19 BUD: 10/25/2021

Distribution

Distribution scope not specified by the agency.