The Recall Desk
SevereFDA (Drugs)·D-0154-2022·Announced 2021-11-17

Talon Compounding Pharmacy Injectable Sterility Recall

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Test Cypionate 200mg/Anastrozole 0.5mg/Dutasteride 1mg/ml injectable (4 vials) due to lack of assurance of sterility.

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 product. The lack of assurance of sterility in injectable compounded medications presents a significant risk of serious infection and potential hospitalization, meeting the criteria for a Severe classification.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Test Cypionate 200mg/Anastrozole 0.5mg/Dutasteride 1mg/ml #2 injectable in 4-vial packages due to lack of assurance of sterility. The recalled product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.

Affected lot numbers are T1008252021:29 (Beyond-Use Date 02/21/2022) and T1006042021:51 (Beyond-Use Date 12/01/2021). Patients who have received doses from these lots should consult their healthcare provider immediately.

Consumers and healthcare providers should not use the recalled product. Those with questions should contact the recalling firm at the address listed: Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.

The recalled product

Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1MG/ML #2 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
  • injection-safety

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 (2)

  • Lot: T1008252021:29 BUD: 02/21/2022
  • T1006042021:51 BUD: 12/01/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category