Testosterone Cypionate/Anastrozole Injectable Recalled for Sterility Assurance Lack
Talon Compounding Pharmacy is recalling testosterone cypionate and anastrozole injectable medication because the manufacturer cannot assure the products were manufactured under sterile conditions. Affected patients should consult their healthcare provider.
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 an injectable pharmaceutical product. Lack of sterility assurance in injectable medications poses a significant risk of serious infection or injury (including bacterial contamination, abscess formation, and systemic infection), meeting the "Severe" threshold even in the absence of reported illnesses.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 200mg/anastrozole 1mg/mL #2 in sesame oil injectable solution distributed across the United States, including Washington, D.C. and Puerto Rico.
The recall was issued because there is a lack of assurance of sterility for the product. The affected lot numbers are T1004202021:52 (BUD 10/17/2021) and T1005042021:24 (BUD 10/31/2021). A total of 6 vials are subject to this recall.
Patients who have received this medication should contact their healthcare provider to discuss their treatment options and potential next steps. Patients should not stop taking prescribed medication without speaking to their healthcare provider first.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1MG/ML #2 IN SESAME 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
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance
- contamination-risk
- injectable-safety
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: T1004202021:52 BUD: 10/17/2021
- T1005042021:24 BUD: 10/31/2021
Distribution
Distribution scope not specified by the agency.
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