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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Hazard
- lack-of-sterility
- infection-risk
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
Distribution scope not specified by the agency.
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