Carolina Infusion, Llc: Tri-mix (papav/phento/alpros),30/2/40
Recall Summary Carolina Infusion, LLC is recalling Tri-MIX (a compounded injectable medication containing papaverine, phentolamine, and alprostadil) distributed nationwide because the company cannot guarantee the product is sterile. The sterility issue is related to the use of bacteriostatic water in formulation and problems with the processing equipment used to compound the product. The medication was supplied in single-use dosage syringes prepared according to individual patient prescriptions.
- Recalling firm
- Carolina Infusion, LLC
- Product
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, 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 formulation using bacteriostic water; 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/b40a29f8-8dcb-464d-b4ec-cf68c5ddd793