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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Category
- Drug — Compounded Injectable
- Affected units
- 1
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
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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