Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class II · Moderate risk
Volumex (Iodinated I 131 Albumin)
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class II · Moderate risk
DelNido Cardioplegia
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1500 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1250 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Vancomycin 1000 mg in NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Sodium Citrate 4%
Lack of sterility assurance.
Class II · Moderate risk
Sodium Bicarbonate 150 mEq in D5W 1000 mL bags
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine 20 mg NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine 0.8 mg/10 mL NS
Lack of sterility assurance.
Class II · Moderate risk
Heparin Pork 30
Lack of sterility assurance.
Class II · Moderate risk
Chlorothiazide 100 mg
Lack of sterility assurance.
Class II · Moderate risk
CefTRIAXone 1 GM
Lack of sterility assurance.
Class II · Moderate risk
CeFAZolin 3 gm 100 mg/mL
Lack of sterility assurance.
Class II · Moderate risk
CeFAZolin 2 GM a) in NS 100 mL bag
Lack of sterility assurance.
Class II · Moderate risk
CeFAZolin 1 GM a) in NS 100 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1
Lack of sterility assurance.