The Recall Desk
SevereFDA (Drugs)·D-0184-2022·Announced 2021-11-17

Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 50mg/mL injectable vials because the manufacturer cannot assure that the product is sterile. The affected product was 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 of a sterile injectable product with no assurance of sterility. Class II recalls with potential for serious adverse health consequences in a sterile injectable context meet the Severe threshold, as loss of sterility in injectable products poses risk of serious infection and systemic complications.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 50mg/mL injectable in ethyl oleate. The product is being recalled due to lack of assurance of sterility.

The recalled product consists of 40 vials with the following lot numbers and beyond-use dates: Lot T0207282021:32 (BUD 11/20/2021), Lot T0508162021:62 (BUD 02/12/2022), Lot T0505242021:00 (BUD 11/20/2021), and Lot T0207232021:23 (BUD 11/20/2021). The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.

Patients who have received this product should consult with their healthcare provider if they have any concerns. Healthcare providers who dispensed this product should contact patients to inform them of the recall.

The recalled product

Product
TESTOSTERONE CYPIONATE 50MG/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
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 (4)

  • Lot: T0207282021:32 BUD: 11/20/2021
  • T0508162021:62 BUD: 02/12/2022
  • T0505242021:00 BUD: 11/20/2021
  • T0207232021:23 BUD: 11/20/2021

Distribution

Distribution scope not specified by the agency.

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