Tri-Mix Papaverine Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 3/PGE-1 100 injectable due to lack of assurance of sterility. The affected lot was 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 of an injectable drug where sterility assurance has failed. Non-sterile injectables present a direct risk of serious infection. Although no illnesses are reported in the source text, the nature of the hazard (contamination of a sterile product) and the injectable route of administration meet the threshold for Severe (Class II with significant risk of harm).
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 30/Phentolamine 3/PGE-1 100 injectable (Rx only) due to lack of assurance of sterility. The product is a prescription injectable medication.
The recalled product lot (06212021:35, with a beyond-use date of 10/23/2021) was distributed to customers across the United States, including Washington, D.C. and Puerto Rico.
Non-sterile injectables pose a risk of serious infection. Patients who have received doses from this lot should consult their healthcare provider immediately about their treatment and any symptoms of infection.
Healthcare providers and patients should cease use of this product and dispose of it appropriately. Questions about this recall can be directed to the FDA or the recalling pharmacy.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 3/PGE-1 100 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- 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: 06212021:35 BUD: 10/23/2021
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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