CGMP Deviations;
Drugs Recalls
Prescription and over-the-counter medications
TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Lack of Assurance of Sterility
Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Lack of Assurance of Sterility
Microbial contamination of non-sterile products.
TEST 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.
Carolina Infusion
Lack of Assurance of Sterility
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Microbial contamination of non-sterile products.
TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Lack of Assurance of Sterility
TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Lack of Assurance of Sterility
TEST 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.
Carolina Infusion
Lack of Assurance of Sterility
TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Lack of Assurance of Sterility
TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Lack of Assurance of Sterility
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Lack of Assurance of Sterility
CGMP Deviations
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Microbial contamination of non-sterile products.
Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in Net Wt 6 oz. aluminum spray can, Distributed by: Edgewell Personal Care Brands, LLC, Shelton, CT 06484, UPC 0 79656 04041 8
Edgewell Personal Care Brands
Chemical contamination: presence of benzene