The Recall Desk
HighFDA (Drugs)·D-0168-2022·Announced 2021-11-17

Testosterone Bi-Blend Injectable Recalled for Lack of Sterility Assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Bi-Blend 100/100 mg/mL injectable due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.

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: This is a Class II recall of a compounded injectable drug involving a fundamental safety defect (lack of sterility assurance), which poses a direct risk of serious injury or infection if the product is non-sterile. Although no illnesses or injuries are reported in the source text, the potential for harm from non-sterile injectable products is significant, meeting the High (3) threshold for risk-of-harm products without reported illness.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Bi-Blend 100/100 mg/mL injectable (Rx only) due to lack of assurance of sterility. The product is manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.

The recalled product includes vials with the following lot codes and beyond-use dates: Lot T7.803162021:08 (BUD 09/12/2021) and Lot TBB07142021:68 (BUD 01/10/2022). The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.

Patients currently using this product should contact their healthcare provider or pharmacist for guidance. Consumers should not use the recalled product and should contact Talon Compounding Pharmacy or their healthcare provider with questions about obtaining a replacement or alternative treatment.

The recalled product

Product
TESTOSTERONE BI-BLEND 100/100MG/ML 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 — Compounded Injectable
Hazard
  • sterility-defect
  • 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: T7.803162021:08 BUD: 09/12/2021
  • TBB07142021:68 BUD: 01/10/2022

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category