Tri-Mix Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling one lot of Tri-Mix Papaverine 25MG/Phentolamine 1MG/PGE1 25MCG/ML Injectable 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an injectable drug due to lack of sterility assurance presents a high risk of harm, as non-sterile injectables can cause serious infection and other adverse effects. No illnesses or injuries have been reported in the source text, making this a risk-of-harm scenario without reported harm.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 25MG/Phentolamine 1MG/PGE1 25MCG/ML Injectable (Lot 08312021:13, BUD 02/08/2022) because the firm cannot assure that the product meets sterility requirements.
The recalled product was distributed throughout the United States including Washington, D.C. and Puerto Rico. The injectable is a prescription-only medication supplied in single 1-vial units.
Consumers and healthcare providers who have received this product should stop use and contact Vita Pharmacy, LLC dba Talon Compounding Pharmacy or their healthcare provider for further guidance regarding any product already dispensed or administered.
The recalled product
- Product
- TRI-MIX PAPAVERINE 25MG/PHENTOLAMINE 1MG/PGE1 25MCG/ML INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable
- 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: 08312021:13 BUD: 02/08/2022
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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