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 (PAPAV/PHENTO/ALPROS) injectable medication due to concerns that the product may not be sterile. The issue stems from the use of bacteriostatic water in formulation and potential contamination from processing equipment used during compounding.
- Check if you have Tri-MIX lot 07212026@1 with BUD (beyond-use date) of 9/10/2026.
- Do not use the recalled product.
- Contact your healthcare provider or pharmacy immediately for guidance on safe alternatives or a replacement prescription.
- Consult your pharmacy or Carolina Infusion LLC for instructions on returning or disposing of the product.
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
10 ml -in patient specific syringe dose
Manufactured in
95 Bees Creek Rd, N/A, Ridgeland, SC, United States
Products
Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0031-2027More 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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