Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 50mg/mL injectable vials because the manufacturer cannot assure that the product is sterile. The affected product 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 an FDA Class II recall of a sterile injectable product with no assurance of sterility. Class II recalls with potential for serious adverse health consequences in a sterile injectable context meet the Severe threshold, as loss of sterility in injectable products poses risk of serious infection and systemic complications.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 50mg/mL injectable in ethyl oleate. The product is being recalled due to lack of assurance of sterility.
The recalled product consists of 40 vials with the following lot numbers and beyond-use dates: Lot T0207282021:32 (BUD 11/20/2021), Lot T0508162021:62 (BUD 02/12/2022), Lot T0505242021:00 (BUD 11/20/2021), and Lot T0207232021:23 (BUD 11/20/2021). The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Patients who have received this product should consult with their healthcare provider if they have any concerns. Healthcare providers who dispensed this product should contact patients to inform them of the recall.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 50MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- Affected units
- 40
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 (4)
- Lot: T0207282021:32 BUD: 11/20/2021
- T0508162021:62 BUD: 02/12/2022
- T0505242021:00 BUD: 11/20/2021
- T0207232021:23 BUD: 11/20/2021
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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