Class II · Moderate risk
Test Cyp/Prop/Deca-Nan 125mg/Ml
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
FDA Drug Recalls
299 recalls, newest first
Class II · Moderate risk
Test Cyp/Prop 160/40mg/Ml Mdv in Ethyl Oleate
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Test Cyp 50mg/Ml in Ethyl Oleate Oil
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Test Cyp 25mg/Ml in Ethyl Oleate Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Test Cyp 200mg/Ml Mdv Ethyl Oleate
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Test Cyp 200mg/Ml in Sesame Oil Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Test Cyp 100mg/Ml in Ethyl Oleate Oil
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Pyridoxine HCL
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Levocarnitine 100mg/Ml Mdv Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Hydroxyprog Caproate 250mg/Ml Oil Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Glutathione 200mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Estradiol Valerate 5mg/Ml Mdv Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Dexpanthenol 250mg/Ml Inj Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Cyclosporine 2% Mct Oil Susp
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Cyclosporin 0.2% Oil Opth Susp
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Ascorbic/Glutathione 1.25/1.25% Opth Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Levocarnitine 100mg/Ml Mdv Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Magnesium Chloride
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Calcium Chloride
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Sodium Bicarbonate in 5% Dextrose Injection
Lack of Assurance of Sterility
Class I · High risk
Sodium Bicarbonate in 5% Dextrose Injection
Non-Sterility: firm's third party lab confirmed microbial contamination.
Class II · Moderate risk
Fludarabine Phosphate for Injection
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Class II · Moderate risk
Succinylcholine Chloride 100 mg/5 mL
Lack of sterility assurance