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Subpotent Drug.
CGMP deviation: Product found to contain trace amounts of NMBA
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Failed Dissolution Specifications
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected