Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling testosterone cypionate 20 mg/mL injectable due to lack of assurance of sterility. The product was distributed across the United States, 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: The FDA has classified this as a Class II recall. Lack of sterility assurance for an injectable drug presents a serious risk of infection or other adverse outcomes to patients receiving the product, meeting the threshold for a Severe classification.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247, is recalling testosterone cypionate 20 mg/mL injectable in ethyl oleate due to lack of assurance of sterility. The affected product includes seven vials distributed across the United States, Washington D.C., and Puerto Rico.
The recall includes the following lot numbers and beyond-use dates: T0507152021:64 (BUD 01/11/2022), T0507232021:35 (BUD 01/19/2022), and T0507292021:15 (BUD 01/25/2022).
Consumers who have received this prescription product should contact their healthcare provider or pharmacy for guidance. This is a prescription-only medication, and patients should not discontinue use without medical advice.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 20MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 7
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 (3)
- Lot: T0507152021:64 BUD: 01/11/2022
- T0507232021:35 BUD: 01/19/2022
- T0507292021:15 BUD: 01/25/2022
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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