The Recall Desk
SevereFDA (Drugs)·D-0173-2022·Announced 2021-11-17

Injectable testosterone cypionate/anastrozole lacks sterility assurance

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling injectable testosterone cypionate 200mg/anastrozole 0.75mg/ml due to lack of assurance of sterility. The recall affects specific lots distributed across the United States, 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: The source text identifies this as an FDA Class II recall. Lack of sterility assurance in injectable products poses a significant risk of serious adverse health effects including infection, bacteremia, and sepsis. Although no specific illnesses or hospitalizations are reported in the source text, the inherent hazard of non-sterile injectables warrants a Severe classification per the rubric's Class II criterion.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.75MG/ML IN OIL INJECTABLE (Rx only) due to lack of assurance of sterility.

The affected product was distributed throughout the United States, including Washington D.C. and Puerto Rico. The recall involves four vials from two specific lots: Lot T1008032021:52 with a beyond-use date of 01/30/2022, and Lot T1008192021:96 with a beyond-use date of 02/15/2022.

Consumers who have received this product should contact their healthcare provider or pharmacist for guidance. Individuals should not use the recalled product.

For additional information, patients and healthcare providers can contact the FDA or the recalling firm.

The recalled product

Product
TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 0.75MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Manufacturer
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Hazard
  • lack-of-sterility
  • injection-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 (2)

  • Lot: T1008032021:52 BUD: 01/30/2022
  • T1008192021:96 BUD: 02/15/2022

Distribution

Distribution scope not specified by the agency.