Perfil del fabricante
Amneal Pharmaceuticals NY LLC
Compañía farmacéutica4 productos registrados
4
productos registrados
82.223
notificaciones totales
16
retiradas registradas
64,7%
graves en total
Productos
mostrando 4 de 4
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| — | 43.079 | problema de adhesión del dispositivo | 15 | |
| 2008 | 22.647 | Aumento del recuento de plaquetas | 1 | |
| — | 9456 | Metahemoglobinemia | 0 | |
| 1997 | 7041 | Migraña | 0 |
Historial de retiradas · 12 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 16 may 2024 | III | Failed Impurities/Degradation Specifications. | Zydus Pharmaceuticals (USA) Inc |
| 21 feb 2023 | III | Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point. | Padagis US LLC |
| 16 abr 2021 | II | Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals Inc |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 11 may 2019 | I | Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour. | Novartis Pharmaceuticals Corp. |
| 7 sept 2018 | II | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. |
| 7 sept 2018 | II | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. |
| 4 may 2018 | II | Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals, Inc. |
| 4 may 2018 | II | Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin. | Noven Pharmaceuticals, Inc. |
| 26 feb 2018 | II | Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product. | Paddock Laboratories, LLC. |
| 27 abr 2017 | III | Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH. | Noven Pharmaceuticals, Inc. |
| 25 feb 2015 | II | Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions. | Noven Pharmaceuticals, Inc. |
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 NY 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.