Injectable Compounded Drug Recall: Sterility Assurance Failure
Vita Pharmacy, LLC (Talon Compounding Pharmacy) is recalling Test Cypionate 200mg/Dutasteride 2mg/mL injectable due to lack of sterility assurance. The affected lot was distributed across 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 a Class II recall of a compounded injectable product with no illnesses or injuries reported in the source. The hazard (loss of sterility assurance) represents a potential risk of serious harm from infection in an injectable preparation, which qualifies as a high-risk-of-harm product per the severity rubric.
Plain-English summary
Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy (located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247), is recalling Test Cypionate 200mg/Dutasteride 2mg/mL in oil for injectable use. This is a prescription-only product.
The recall is due to lack of assurance of sterility. Lot T1007222021:38 with a beyond-use date of 01/18/2022 is affected. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
Persons who have received this product should consult their healthcare provider immediately. Healthcare providers and patients with questions should contact the recalling firm or the FDA.
The recalled product
- Product
- TEST CYPIONATE 200MG/DUTASTERIDE 2MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- 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: T1007222021:38 BUD: 01/18/2022
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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