Injectable steroid compound recalled due to lack of sterility assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable pharmaceutical compound containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility. The recall affects one lot distributed in the United States.
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 an FDA Class II recall of an injectable pharmaceutical product where sterility cannot be assured. Lack of sterility in injectable products creates a high risk of serious infection and other harm, and the source text does not state that illnesses have been reported, making this a high-risk theoretical hazard rather than a confirmed critical event.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE because the manufacturer cannot assure that the product meets sterility standards.
The recalled product was distributed to patients in the United States, including Washington, D.C. and Puerto Rico. The specific lot affected is T1006032021:45 with a beyond-use date of 11/30/2021. Four vials were distributed as part of this lot.
Consumers who have received this product should contact their healthcare provider or pharmacist immediately. Patients should not use the product and should speak with their prescribing physician about appropriate follow-up care. Healthcare providers should review their records for any patients who may have received injections from this lot.
The recalled product
- Product
- TEST CYPIONATE 200MG/ANASTROZOLE 2MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 4
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: T1006032021:45 BUD: 11/30/2021
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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