The Recall Desk
SevereFDA (Drugs)·D-0179-2022·Announced 2021-11-17

Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/mL injectable vials distributed across the United States 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 drug product. Lack of sterility assurance in injectable medications poses a risk of serious infection, which meets the criteria for a Severe rating even in the absence of reported illnesses.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/mL injectable (Ethyl Oleate) due to lack of assurance of sterility. The product is a prescription-only injectable medication manufactured by the recalling firm.

Approximately 1,229 vials have been distributed throughout the United States, including Washington, D.C. and Puerto Rico. The recall affects multiple lots with varying beyond-use dates (BUDs) ranging from October 2021 through March 2022.

Consumers who have received this product should contact their healthcare provider or pharmacy immediately. Healthcare providers should not dispense the recalled product and should take steps to retrieve any distributed vials from patients.

The recalled product

Product
TESTOSTERONE CYPIONATE 200MG/ML INJ #1 IN ETHYL OLEATE 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 Medication
Hazard
  • lack-of-sterility
  • contamination-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 (20)

  • Lot: T1007302021:72 BUD: 01/26/2022
  • T1005182021:09 BUD: 11/15/2021
  • T1008112021:73 BUD: 02/07/2022
  • T1004092021:40 BUD: 10/09/2021
  • T1006182021:37 BUD: 12/15/2021
  • T1005242021:71 BUD: 11/20/2021
  • T1006072021:06 BUD: 12/04/2021
  • T0606222021:35 BUD: 12/19/2021
  • T0605112021:23 BUD:11/07/2021
  • T0608162021:19 BUD: 02/12/2022
  • T1009132021:25 BUD: 03/12/2022
  • T1004272021:41 BUD: 10/24/2021
  • T0604152021:26 BUD: 10/12/2021
  • T1006302021:53 BUD: 12/27/2021
  • T1008022021:01 BUD: 01/29/2022
  • T1008302021:73 BUD: 02/26/2022
  • T1008052021:84 BUD: 02/01/2022
  • T1007152021:72 BUD: 01/11/2022
  • T1005112021:54 BUD: 11/07/2021
  • T1008042021:66 BUD: 01/31/2022

Distribution

Distribution scope not specified by the agency.

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