Carolina Infusion, Llc: Tri-mix (papav/phento/alpros),30/1/60, Injectable
Recall Summary Carolina Infusion, LLC is recalling Tri-MIX injectable medication (a combination of papaverine, phentolamine, and alprostadil) distributed nationwide because the equipment used to compound the product cannot be assured to be sterile. The medication was packaged in single-use syringes with doses customized per patient prescriptions. This is a Class II recall, meaning there is a potential health hazard but the product is unlikely to cause serious harm.
- Recalling firm
- Carolina Infusion, LLC
- Product
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
- Reason
- Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-10
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the U.S
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/55443fa4-3d21-4a8c-b836-f9bcd1795b89