TRI-TEST 200 Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-TEST 200 injectable medication due to lack of assurance of sterility. Affected lots include T1007302021:37 and T1008242021:04.
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 sterility assurance failure in an injectable drug. Loss of sterility assurance in injectable medications poses a direct risk of serious infection and is classified as a severe safety hazard under the rubric criteria for Class II recalls with risk of serious adverse outcomes.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-TEST 200 (CY50%-EN37.5%-PR12.5%) injectable medication distributed in the United States, including Washington, D.C. and Puerto Rico. The recall affects 4 vials with lot numbers T1007302021:37 (BUD 01/26/2022) and T1008242021:04 (BUD 02/20/2022).
The reason for the recall is lack of assurance of sterility. Sterility is a critical requirement for injectable medications to prevent serious infections.
Patients who have received doses from these lots should contact their healthcare provider immediately. Healthcare providers should review patient records to identify those who may have received the affected product and take appropriate action.
The recalled product
- Product
- TRI-TEST 200 (CY50%-EN37.5%-PR12.5%) INJ #1 200MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- Affected units
- 4
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 (2)
- Lot: T1007302021:37 BUD: 01/26/2022
- T1008242021:04 BUD: 02/20/2022
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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