The Recall Desk
SevereFDA (Drugs)·D-0176-2022·Announced 2021-11-17

Testosterone Cypionate/Anastrozole Injectable Recalled for Lack of Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 200 mg/anastrozole 1.75 mg/mL injectable due to lack of assurance of sterility. The affected lot was 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: This is a Class II drug recall involving a sterile injectable product with a documented lack of sterility assurance. Non-sterile injectables pose significant risk of serious infection and potential hospitalization, meeting the Severe criteria for Class II recalls with serious injury risk.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200 mg/Anastrozole 1.75 mg/mL in oil, injectable (Rx only) due to lack of assurance of sterility. The recalled product was manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.

The affected lot is T1007132021:95 with a beyond-use date (BUD) of 01/09/2022. The product is supplied in 2-vial units and was distributed throughout the United States including Washington, D.C. and Puerto Rico.

Patients who have received this product should consult their healthcare provider about appropriate follow-up care. Healthcare providers and patients with questions about this recall should contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy.

The recalled product

Product
TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.75MG/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
Category
Drug — Injectable Hormone
Hazard
  • lack-of-sterility
  • 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 (1)

  • Lot: T1007132021:95 BUD: 01/09/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category