The Recall Desk
HighFDA (Drugs)·D-0153-2022·Announced 2021-11-17

Injectable anabolic steroid compound recalled for lack of sterility assurance

Talon Compounding Pharmacy is recalling an injectable testosterone cypionate compound because the manufacturer cannot assure the product is sterile. The affected vials were distributed across the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA classified this as a Class II recall. The hazard is a lack of sterility assurance in an injectable product, which poses a risk of serious infection and harm. No reported illnesses or injuries are stated in the source, so the score is capped at 3 per the rubric; however, the theoretical risk from a non-sterile injectable justifies the "High" label.

Plain-English summary

Vita Pharmacy, LLC (dba Talon Compounding Pharmacy) is recalling TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1.5MG/ML IN OIL INJECTABLE (4 vials) because the product lacks assurance of sterility.

The recalled product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. The affected lots are T1007012021:96 (BUD 12/28/2021) and T1008192021:04 (BUD 02/15/2022).

Consumers who have received this product should consult their healthcare provider or pharmacist immediately for guidance. The product is prescription-only and distributed through pharmacies.

The recalled product

Product
TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 1.5MG/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
Hazard
  • lack-of-sterility
  • 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 (2)

  • Lot: T1007012021:96 BUD: 12/28/2021
  • T1008192021:04 BUD: 02/15/2022

Distribution

Distribution scope not specified by the agency.