Carolina Infusion, Llc: Quad-mix( Papav/phento/alpros/trop) Injectable
Recall Summary Carolina Infusion, LLC is recalling QUAD-MIX injectable medication (a compounded drug containing papaverine, phentolamine, alprostadil, and tropicamide) distributed nationwide because the processing equipment used to make it could not be confirmed as sterile. The medication was dispensed in single-use syringes according to individual patient prescriptions. This is a Class II recall, meaning the product could cause serious health problems or death.
- Recalling firm
- Carolina Infusion, LLC
- Product
- QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) 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/1d98a782-1216-4fba-8cbd-7f2042d633a6