BI-MIX Papaverine/Phentolamine Injectable Recalled for Sterility Assurance
Talon Compounding Pharmacy is recalling BI-MIX Papaverine 40/Phentolamine 2 injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States, Washington D.C., and Puerto Rico.
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 assurance is compromised. Non-sterile injectable products present direct risk of serious infection and may require hospitalization. Class II recalls of sterile injectables warrant a Severe classification per the rubric.
Plain-English summary
Talon Compounding Pharmacy, operating as Vita Pharmacy, LLC, is recalling BI-MIX Papaverine 40/Phentolamine 2 injectable medication distributed as a 1 vial package. The product is a prescription-only injectable formulation.
The recall was issued because there is a lack of assurance of sterility for the affected vials. This injectable medication is intended for direct administration and therefore requires strict sterility standards to prevent infection and contamination.
The recalled product has lot number 08182021:00 with a beyond-use date of 12/16/2021, and was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Consumers who have received this medication should contact their healthcare provider or pharmacist immediately. Do not use the recalled vials. Healthcare providers and patients should return the product to the pharmacy or manufacturer for proper disposal.
The recalled product
- Product
- BI-MIX PAPAVERINE 40/PHENTOLAMINE 2 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
- injectable-contamination
- 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: 08182021:00 BUD: 12/16/2021
Distribution
Distribution scope not specified by the agency.
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