The Recall Desk
SevereFDA (Drugs)·D-0162-2022·Announced 2021-11-17

Talon Compounding Pharmacy Injectable Steroid Mixture Recall for Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable anabolic steroid mixture (Test Cypionate 200mg/Anastrozole 1mg/Dutasteride 2mg/mL in oil) due to lack of assurance of sterility. The recall affects products distributed throughout 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 an injectable pharmaceutical product with a sterility defect. Non-sterile injectables carry substantial risk of serious infection and complications including sepsis and localized infection at injection sites, meeting the Severe classification criterion.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25 in San Antonio, Texas, is recalling an injectable pharmaceutical preparation containing Test Cypionate 200mg, Anastrozole 1mg, and Dutasteride 2mg per milliliter in an oil base. The prescription-only product was distributed in 6-vial packages across the United States, including Washington, D.C. and Puerto Rico.

The recall was initiated because the manufacturer cannot assure that the product meets sterility standards. The affected lots are: T1009222021:34 (BUD 03/21/2022), T1008022021:71 (BUD 01/29/2022), and T1006072021:73 (BUD 12/04/2021).

Consumers and healthcare providers who have received this product should not use it and should contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy for further instructions regarding return or disposal. Non-sterile injectable products pose a potential risk to patient safety.

The recalled product

Product
TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 2MG/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
  • lack-of-sterility
  • contamination-risk
  • 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: T1009222021:34 BUD: 03/21/2022
  • T1008022021:71 BUD: 01/29/2022
  • T1006072021:73 BUD: 12/04/2021

Distribution

Distribution scope not specified by the agency.

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