Class I - Dangerous
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
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
Class I - Dangerous
Chemical contamination: presence of benzene
L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Microbial contamination of non-sterile products.
Microbial contamination of non-sterile products.
TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility
QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Microbial contamination of non-sterile products.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products.