Class II · Moderate risk
Losartan Potassium / 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 drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Losartan Potassium / 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
Losartan Potassium Tablets USP
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class II · Moderate risk
Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk
Telmisartan and Hyrdochlorothiazide Tablets
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk
Tamsulosin Hydrochloride Capsules
Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Class II · Moderate risk
Gentamicin Sulfate Ophthalmic Solution
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 17.44-0.64mg-5.8mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 17.44-0.58mg-5.8mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 15-0.25mg-6mcg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 30-1 Mg-20 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 9-1 Mg-10 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 22.5-0.8mg-8.3mcg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 17.64-0.58mg-5.88mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 16.6-0.55 Mg-11.1 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 15-0.5mg-10mcg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine-Pge1 30-2 Mg-30 Mcg/Ml* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine 30-0.5 Mg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Papaverine-Phentolamine 15-0.5mgmg/Ml Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.