Class II · Moderate risk Terminated
Edetate Disodium 15% Injectable
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Edetate Disodium 30% Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Edetate Calcium Disodium 150mg/Ml Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dimercapto-Propanesulfonic 5%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
diazePAM 5 MG/ML INJECTION SOLUTION
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dextrose 50% Injection Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dextrose 50% Injection Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Dexpanthenol 250mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyancobalamin 1200mcg/Ml Mdv Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Copper 0.4MG/ML
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Gluconate 5% Injection Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Chloride 100mg/Ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Buffered Lidocaine HCL 1% Injection Sol
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Buffered Lidocaine HCL 1% Injection Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Buffered Lidocaine 1%+epi 1:100
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Avastin
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ascorbic Acid 500 MG/ML
Reason Crystallization
Class II · Moderate risk Terminated
Ascorbic Acid 400 MG/ML
Reason Crystallization
Class II · Moderate risk Terminated
Ascorbic Acid 500 MG/ML
Reason Crystallization
Class II · Moderate risk Terminated
SUCCINYLcholine Chloride
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk Terminated
SUCCINYLcholine Chloride
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk Terminated
Sodium Bicarbonate INJ 8.4%
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk Terminated
Riboflavin 5-Phosphate Sodium Ophthalmic Solution
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk Terminated
Phenylephrine HCL PF INJ in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk Terminated
Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.