FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion Tri-MIX injectable recalled for sterility assurance failure
What this means
Carolina Infusion, LLC is recalling Tri-MIX (papaverine/phentolamine/alprostadil) injectable solution due to a sterility assurance issue related to processing equipment used during compounding. The product is dispensed in single-use syringes and was distributed nationwide. No injuries have been reported to date.
- Check if you have received Tri-MIX from Carolina Infusion with lot number 07242026@7 and expiration date 09/7/2026.
- Do not use the product if you have it on hand.
- Contact your healthcare provider or pharmacy immediately for guidance on your treatment.
The agency's original wording
Hazard
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
5 mL in patient specific syringe doses
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, 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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0023-2027More 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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