Carolina Infusion, Llc: Tri-mix (papav/phento/alpros),30/2/20, Injectable
Recall Summary Carolina Infusion, LLC is recalling Tri-MIX injectable medication (a combination of papaverine, phentolamine, and alprostadil) distributed nationwide because the company cannot guarantee the product is sterile. The sterility issue stems from the use of bacteriostatic water in formulation and concerns with the processing equipment used to make the product. This is a Class II recall, meaning the product could cause serious health consequences or death.
- Recalling firm
- Carolina Infusion, LLC
- Product
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, 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 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/22732c95-acdc-4b81-9ca5-90ba4afdac43