The Recall Desk
SevereFDA (Drugs)·D-0169-2022·Announced 2021-11-17

Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance

Talon Compounding Pharmacy is recalling testosterone cypionate 100 mg/mL injectable in 12 lots due to lack of assurance of sterility. The affected product was 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: This is an FDA Class II recall. Non-sterile injectable products pose a significant risk of serious infection, which meets the Severe category criteria for products with potential for serious injury even without reported cases.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 100 mg/mL injectable (Rx only) distributed under their name from their San Antonio, Texas location. The recall affects 168 vials across 12 lots with various beyond-use dates ranging from November 2021 through March 2022.

The recall is due to lack of assurance of sterility. Non-sterile injectables pose a risk of infection when administered.

The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients using this product should consult their healthcare provider immediately regarding their treatment.

The affected lot numbers and corresponding beyond-use dates are: T0204272021:49 (10/24/2021), T0206142021:55 (12/11/2021), T0209082021:74 (03/07/2022), T0506212021:52 (12/18/2021), T0207082021:41 (01/04/2022), T0208112021:07 (02/07/2022), T0206012021:26 (11/28/2021), T0507122021:00 (01/08/2022), T0505112021:58 (11/07/2021), T0205182021:56 (11/14/2021), T0506102021:88 (12/07/2021), and T0508182021:56 (02/14/2022).

The recalled product

Product
TESTOSTERONE CYPIONATE 100MG/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
  • sterility-failure
  • 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 (12)

  • Lot: T0204272021:49 BUD: 10/24/2021
  • T0206142021:55 BUD: 12/11/2021
  • T0209082021:74 BUD: 03/07/2022
  • T0506212021:52 BUD: 12/18/2021
  • T0207082021:41 BUD: 01/04/2022
  • T0208112021:07 BUD: 02/07/2022
  • T0206012021:26 BUD: 11/28/2021
  • T0507122021:00 BUD: 01/08/2022
  • T0505112021:58 BUD: 11/07/2021
  • T0205182021:56 BUD: 11/14/2021
  • T0506102021:88 BUD: 12/07/2021
  • T0508182021:56 BUD: 02/14/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category