Carolina Infusion, Llc: Tri-mix (papav/phento/alpros),30/1/20, Injectable
Recall Summary Carolina Infusion, LLC is recalling Tri-MIX injectable medication (a compounded product containing papaverine, phentolamine, and alprostadil) distributed nationwide because the company cannot guarantee the product is sterile due to issues with processing equipment used to make it. The medication was dispensed in single-use syringes according to individual patient prescriptions.
- Recalling firm
- Carolina Infusion, LLC
- Product
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, 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/898dd1fb-f89c-446f-b3cf-a62b74a7b31f