Recall Enforment Report D-1529-2022

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Carolina Infusion, originally initiated on 08-26-2022 for the product TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1529-202208-26-202209-21-2022Class II3 vialsTRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1526-202208-26-202209-21-2022Class II16 vialsTRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1522-202208-26-202209-21-2022Class II2 vialsTEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1530-202208-26-202209-21-2022Class II11 vialsTRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1528-202208-26-202209-21-2022Class II2 vialsTRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1519-202208-26-202209-21-2022Class II24 syringesSemaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1523-202208-26-202209-21-2022Class II3 vialsTEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1524-202208-26-202209-21-2022Class II348 vialsTEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1525-202208-26-202209-21-2022Class II1 vialTEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1533-202208-26-202209-21-2022Class II1 vialQUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1527-202208-26-202209-21-2022Class II7 vialsTRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1521-202208-26-202209-21-2022Class II4 syringesSemaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1516-202208-26-202209-21-2022Class II3 vialsMIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1531-202208-26-202209-21-2022Class II2 vialsTRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1520-202208-26-202209-21-2022Class II4 syringesSemaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1517-202208-26-202209-21-2022Class II4 vialsMIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1518-202208-26-202209-21-2022Class II8 syringesSermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1515-202208-26-202209-21-2022Class II1 vialL-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1532-202208-26-202209-21-2022Class II1 vialTRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing
D-1534-202208-26-202209-21-2022Class II1 vialQUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.Lack of Assurance of SterilityOngoing