Testosterone Cypionate/Anastrozole Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 200 mg/anastrozole 1.75 mg/mL injectable due to lack of assurance of sterility. The affected lot 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class II drug recall involving a sterile injectable product with a documented lack of sterility assurance. Non-sterile injectables pose significant risk of serious infection and potential hospitalization, meeting the Severe criteria for Class II recalls with serious injury risk.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200 mg/Anastrozole 1.75 mg/mL in oil, injectable (Rx only) due to lack of assurance of sterility. The recalled product was manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.
The affected lot is T1007132021:95 with a beyond-use date (BUD) of 01/09/2022. The product is supplied in 2-vial units and was distributed throughout the United States including Washington, D.C. and Puerto Rico.
Patients who have received this product should consult their healthcare provider about appropriate follow-up care. Healthcare providers and patients with questions about this recall should contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 200MG/ANASTROZOLE 1.75MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable Hormone
- Affected units
- 2
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 (1)
- Lot: T1007132021:95 BUD: 01/09/2022
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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