Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/mL injectable vials distributed across the United States due to lack of assurance of sterility.
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 drug product. Lack of sterility assurance in injectable medications poses a risk of serious infection, which meets the criteria for a Severe rating even in the absence of reported illnesses.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Testosterone Cypionate 200mg/mL injectable (Ethyl Oleate) due to lack of assurance of sterility. The product is a prescription-only injectable medication manufactured by the recalling firm.
Approximately 1,229 vials have been distributed throughout the United States, including Washington, D.C. and Puerto Rico. The recall affects multiple lots with varying beyond-use dates (BUDs) ranging from October 2021 through March 2022.
Consumers who have received this product should contact their healthcare provider or pharmacy immediately. Healthcare providers should not dispense the recalled product and should take steps to retrieve any distributed vials from patients.
The recalled product
- Product
- TESTOSTERONE CYPIONATE 200MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 1,229
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 (20)
- Lot: T1007302021:72 BUD: 01/26/2022
- T1005182021:09 BUD: 11/15/2021
- T1008112021:73 BUD: 02/07/2022
- T1004092021:40 BUD: 10/09/2021
- T1006182021:37 BUD: 12/15/2021
- T1005242021:71 BUD: 11/20/2021
- T1006072021:06 BUD: 12/04/2021
- T0606222021:35 BUD: 12/19/2021
- T0605112021:23 BUD:11/07/2021
- T0608162021:19 BUD: 02/12/2022
- T1009132021:25 BUD: 03/12/2022
- T1004272021:41 BUD: 10/24/2021
- T0604152021:26 BUD: 10/12/2021
- T1006302021:53 BUD: 12/27/2021
- T1008022021:01 BUD: 01/29/2022
- T1008302021:73 BUD: 02/26/2022
- T1008052021:84 BUD: 02/01/2022
- T1007152021:72 BUD: 01/11/2022
- T1005112021:54 BUD: 11/07/2021
- T1008042021:66 BUD: 01/31/2022
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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