FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion Tri-MIX injection recalled for sterility concerns
What this means
Carolina Infusion LLC recalled Tri-MIX (a compounded injection containing papaverine, phentolamine, and alprostadil) due to concerns that the product may not be sterile. The issue stems from the use of bacteriostatic water in the formulation and potential problems with processing equipment.
- If you have received a Tri-MIX injection from Carolina Infusion, contact your healthcare provider immediately
- Do not use the product if you still have it in your possession
- Check the lot numbers: 07282026@2 (BUD 9/11/2026), 08032026@11 (BUD 9/17/2026), and 08042026@3 (BUD 9/18/2026)
The agency's original wording
Hazard
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
20 mLs - in patient specific syringe dose
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0032-2027More Carolina Infusion recalls
- FDA-Drug2026-10-14Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion semaglutide injectable recalled for sterility assurance concerns
- FDA-Drug2026-10-14Carolina Infusion Sermorelin Acetate injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion semaglutide/cyanocobalamin injectable recalled for sterility concerns
- FDA-Drug2026-10-14Carolina Infusion tirzepatide injectable recalled for sterility concerns
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