Talon Compounding Injectable Sterility Recall
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable steroid combination product due to lack of assurance of sterility. The recall affects 13 vials 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 involving a sterile injectable product without confirmed reports of illness. Lack of sterility assurance in injectable medications poses serious potential harm to patients including infection and sepsis, meeting the Severe criteria for Class II recalls involving risk of serious injury.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE due to lack of assurance of sterility. The recalled product is a prescription injectable medication.
The recall involves 13 vials across three lots: Lot T1007072021:98 (BUD 01/03/2022), Lot T1005252021:31 (BUD 11/21/2021), and Lot T1009222021:60 (BUD 03/21/2022). The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Patients who have received this product should consult their healthcare provider or pharmacist. Healthcare providers and patients should not use any remaining product from the affected lots.
The recalled product
- Product
- TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 13
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: T1007072021:98 BUD: 01/03/2022
- T1005252021:31 BUD: 11/21/2021
- T1009222021:60 BUD: 03/21/2022
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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