FDA-Drug2026-10-14Class IIPROCESSING DEFECT
Carolina Infusion Tri-MIX injectable recalled for sterility assurance failure
What this means
Carolina Infusion recalled Tri-MIX (a compounded injectable medication) because processing equipment used to make it may not have been properly sterilized. The affected product is packaged in single-use syringes and was distributed nationwide. This means the medication may not be sterile and could pose a health risk if used.
- If you have a Tri-MIX syringe with lot 08042026@8 and expiration date 9/18/2026, do not use it.
- Contact your healthcare provider or pharmacy to confirm whether you received an affected dose and for guidance on your treatment.
- Return any recalled syringes to your pharmacy or healthcare provider.
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
3 ML in patient specific syringe dose
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, 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-0024-2027More 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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