The Recall Desk
SevereFDA (Drugs)·D-0151-2022·Announced 2021-11-17

Talon Compounding Pharmacy Injectable Drugs Recalled for Lack of Sterility Assurance

Talon Compounding Pharmacy is recalling injectable medications containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility. The recall affects 23 vials distributed across 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: The FDA classified this recall as Class II. The hazard—lack of sterility assurance in injectable medications—presents a significant risk of serious infection or contamination, warranting a Severe classification per the rubric for FDA Class II recalls with serious potential outcomes, even though no specific illnesses or hospitalizations are reported in the source text.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE due to lack of assurance of sterility. The affected product is a prescription-only injectable medication distributed to the United States, including Washington, D.C. and Puerto Rico.

The recall involves 23 vials across six lot numbers with varying beyond-use dates (BUD dates ranging from 12/05/2021 to 03/21/2022). The specific affected lots are: 07292021:54, T1006302021:96, T1008092021:60, T1009222021:51, T1006082021:79, and T1008302021:82.

Patients who have received this product should not use it and should consult their healthcare provider immediately. Healthcare providers should contact their patient records to identify affected individuals and advise them of the recall. The manufacturer is Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.

The recalled product

Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.5MG/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
  • sterility-assurance
  • microbial-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 (6)

  • Lot: 07292021:54 BUD: 01/25/2022
  • T1006302021:96 BUD: 12/27/2021
  • T1008092021:60 BUD: 02/05/2022
  • T1009222021:51 BUD: 03/21/2022
  • T1006082021:79 BUD: 12/05/2021
  • T1008302021:82 BUD: 02/26/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category