The Recall Desk
SevereFDA (Drugs)·D-0159-2022·Announced 2021-11-17

Talon Compounding Injectable Sterility Recall

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable steroid combination product due to lack of assurance of sterility. The recall affects 13 vials 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 sterile injectable product without confirmed reports of illness. Lack of sterility assurance in injectable medications poses serious potential harm to patients including infection and sepsis, meeting the Severe criteria for Class II recalls involving risk of serious injury.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE due to lack of assurance of sterility. The recalled product is a prescription injectable medication.

The recall involves 13 vials across three lots: Lot T1007072021:98 (BUD 01/03/2022), Lot T1005252021:31 (BUD 11/21/2021), and Lot T1009222021:60 (BUD 03/21/2022). The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.

Patients who have received this product should consult their healthcare provider or pharmacist. Healthcare providers and patients should not use any remaining product from the affected lots.

The recalled product

Product
TEST CYPIONATE 200MG/ANASTROZOLE 1MG/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
Hazard
  • lack-of-sterility
  • infection-risk

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: T1007072021:98 BUD: 01/03/2022
  • T1005252021:31 BUD: 11/21/2021
  • T1009222021:60 BUD: 03/21/2022

Distribution

Distribution scope not specified by the agency.