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
95,102 total recalls in our database
Carolina Infusion
Lack of Assurance of Sterility
Carolina Infusion
Lack of Assurance of Sterility
Carolina Infusion
Lack of Assurance of Sterility
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
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.
Edgewell Personal Care Brands
Chemical contamination: presence of benzene
Carolina Infusion
Lack of Assurance of Sterility
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
Carolina Infusion
Lack of Assurance of Sterility
Carolina Infusion
Lack of Assurance of Sterility
Microbial contamination of non-sterile products.
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
Product not registered for use in the UK
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.