TRI-MIX Injectable Papaverine Phentolamine PGE-1 Lacks Sterility Assurance
Vita Pharmacy (Talon Compounding) is recalling TRI-MIX injectable medication (Lot 07142021:43) distributed across the United States because the manufacturer cannot assure the product meets sterility standards.
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 a sterile injectable drug where sterility cannot be assured. Lack of sterility in injectable medications poses a direct risk of serious infection and harm; the source classification as Class II combined with the nature of the hazard (compromised sterility in injectable products) meets the Severe threshold.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ, an injectable prescription medication, due to lack of assurance of sterility.
The recalled product is identified by Lot 07142021:43 with a Beyond Use Date (BUD) of 10/23/2021. The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Injectable medications require strict sterility standards to prevent serious infections and complications. The manufacturer cannot assure this product meets those standards.
Patients who have received this medication should consult their healthcare provider immediately. Healthcare providers should verify whether patients under their care received product from the affected lot and take appropriate clinical action.
The recalled product
- Product
- TRI-MIX PAPAVERINE 30/PHENTOLAMINE 6/PGE-1 60 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 3
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: 07142021:43 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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