Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Affected units: 6

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

Distributed in 2 states:

Part of a larger recall action

This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 130 products in this recall →

Same manufacturer · Vita Pharmacy, LLC dba Talon Compounding Pharmacy

See all →

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FDA (Drugs) · 2021-11-17
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TRI-MIX Injectable by Talon Compounding Pharmacy Recalled for Sterility Assurance
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Severe
Injectable Steroid Combination Product Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17
High
Testosterone Bi-Blend Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2021-11-17

Same hazard · lack of sterility