Prescription and over-the-counter medications
American Health Packaging
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Customceutical Compounding
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Customceutical Compounding
Lack of assurance of sterility for injectables and solutions intended to be sterile.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Customceutical Compounding
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Customceutical Compounding
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Lack of assurance of sterility for injectables and solutions intended to be sterile.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Customceutical Compounding
Lack of assurance of sterility for injectables and solutions intended to be sterile.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Customceutical Compounding
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Customceutical Compounding
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Defective Delivery System: difficult to express
Customceutical Compounding
Lack of assurance of sterility for injectables and solutions intended to be sterile.
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Sub-potency