17,898 recalls, newest first
Reason 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.
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Reason CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Reason Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
Reason Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Reason Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Reason Failed Dissolution Specifications
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Reason CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Reason CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Reason CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Reason Failed Dissolution Specifications; 9-monthstability timepoint
Reason Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Reason Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.