The Recall Desk
SevereFDA (Drugs)·D-0156-2022·Announced 2021-11-17

Talon Compounding Pharmacy Injectable Drug Recalled for Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable combination drug (Lot T1008312021:33) due to lack of assurance of sterility. The affected product 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 an FDA Class II recall involving a sterility defect in an injectable drug product. Injectable products with compromised sterility assurance pose significant risk of serious infection or harm; this classification meets the Severe threshold for Class II recalls with potential for serious injury.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable combination product containing Test Cypionate 200mg, Anastrozole 0.75mg, and Dutasteride 1mg/mL in oil. The recall was initiated due to lack of assurance of sterility.

The recalled product is a 2-vial injectable, prescription-only medication (Lot T1008312021:33, BUD 02/27/2022) manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive, Suite 25, San Antonio, Texas 78247.

The product was distributed across the United States, including Washington, D.C. and Puerto Rico. Patients who have received this product should consult their healthcare provider immediately. Healthcare providers should discontinue use of this lot and contact the pharmacy for guidance on appropriate actions.

The recalled product

Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.75MG/DUTASTERIDE 1MG/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 Compounded Product
Hazard
  • sterility-assurance
  • injectable-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 (1)

  • Lot: T1008312021:33 BUD: 02/27/2022

Distribution

Distribution scope not specified by the agency.

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