Tri-Mix Papaverine Injectable Lacks Assured Sterility, Talon Compounding
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable medication because the manufacturer lacks assurance of sterility. The affected lot was 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 with a fundamental sterility defect. Non-sterile injectables can cause serious infections and may require hospitalization, meeting the Severe severity criterion for Class II recalls with potential for serious health consequences.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine 15/Phentolamine 0.5/PGE-1 5 mg injectable medication. The recall applies to lot 07292021:21 with a Beyond Use Date of 11/30/2021.
The recall was initiated due to lack of assurance of sterility for the product. Non-sterile injectable medications pose a risk of infection to patients receiving the injection.
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients who have received this medication should consult with their healthcare provider about potential exposure to non-sterile product.
The recalled product
- Product
- TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.5/PGE-1 5 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
- sterility-defect
- infection-risk
- injectable-contamination
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: 07292021:21 BUD: 11/30/2021
Distribution
Distribution scope not specified by the agency.
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