TRI-MIX Injectable Medication Recalled for Sterility Assurance Failure
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of TRI-MIX PAPAVERINE/PHENTOLAMINE/PGE-1 injectable due to lack of assurance of sterility. The affected vial 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: This is an FDA Class II recall of an injectable drug with a sterility defect. Lack of sterility assurance in injectable medications directly creates risk of serious systemic infection in patients who receive the product, meeting the criterion for Severe severity.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247, is recalling TRI-MIX PAPAVERINE 26/PHENTOLAMINE 3/PGE-1 60/ML INJ (injectable, prescription-only) due to lack of assurance of sterility.
The affected product is Lot 08192021:32 with a beyond-use date of 02/15/2022. The recall involves 1 vial that was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Injectable medications that lack sterility assurance pose a risk of infection if administered. Consumers or healthcare providers who have this product should not use it and should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- TRI-MIX PAPAVERINE 26/PHENTOLAMINE 3/PGE-1 60/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- Affected units
- 1
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 (1)
- Lot: 08192021:32 BUD: 02/15/2022
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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