Perfil del fabricante
Amneal Pharmaceuticals LLC
Compañía farmacéutica8 productos registrados
8
productos registrados
165.802
notificaciones totales
23
retiradas registradas
86,6%
graves en total
Productos
mostrando 8 de 8
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1990 | 54.798 | Colitis ulcerosa | 10 | |
| 2004 | 36.718 | Progresión de neoplasia maligna | 1 | |
| 2004 | 36.708 | Progresión de neoplasia maligna | 0 | |
| — | 12.505 | Degeneración macular | 4 | |
| 2005 | 11.390 | aumento del ADN del virus de la hepatitis B | 6 | |
| 2008 | 10.727 | Retención urinaria | 2 | |
| — | 1713 | obstrucción de vías respiratorias altas | 0 | |
| 1984 | 1243 | Complicación de la sedación | 0 |
Historial de retiradas · 20 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 16 dic 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| 10 oct 2025 | III | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited |
| 24 sept 2025 | II | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc |
| 24 sept 2025 | II | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc |
| 4 sept 2025 | II | Failed Impurity/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc |
| 4 sept 2025 | II | Failed Impurity/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc |
| 5 feb 2024 | II | Failed Dissolution Specifications: Out of specification for dissolution. | SUN PHARMACEUTICAL INDUSTRIES INC |
| 18 ene 2024 | II | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC |
| 30 oct 2020 | II | Failed Dissolution Specifications | AVKARE Inc. |
| 28 oct 2020 | II | Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. | Teva Pharmaceuticals USA |
| 20 feb 2020 | II | Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. | Teva Pharmaceuticals USA |
| 12 jun 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 20 jul 2017 | II | Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point. | Hetero USA Inc |
| 12 dic 2016 | II | Failed Dissolution Specifications | Amneal Pharmaceuticals LLC |
| 2 dic 2016 | III | Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules | Shire PLC |
| 20 may 2014 | II | Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product. | Cambrex Charles City Inc |
| 2 jul 2013 | II | Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the following drug: CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, NDC 11868000901, Pedigree: AD34928_1, EXP: 5/9/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup; MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD52378_1, EXP: 5/17/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup; MESALAMINE CR, Capsule, 500 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD21790_7, EXP: 5/1/2014. | Aidapak Services, LLC |
| 2 jul 2013 | II | Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the following drugs: ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD30140_25, EXP: 5/7/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: W003686, EXP: 6/26/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD60272_49, EXP: 5/22/2014. | Aidapak Services, LLC |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Amneal Pharmaceuticals LLC no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.