Perfil del fabricante
Bayer HealthCare Pharmaceuticals Inc.
Compañía farmacéutica8 productos registrados
8
productos registrados
173.295
notificaciones totales
9
retiradas registradas
77,4%
graves en total
Productos
mostrando 8 de 8
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 2005 | 51.767 | Lesión de la vesícula biliar | 6 | |
| — | 45.168 | Lesión de la vesícula biliar | 3 | |
| 2013 | 31.875 | Hipertensión arterial pulmonar | 0 | |
| 1993 | 19.028 | Esclerosis múltiple | 0 | |
| 2012 | 11.442 | cáncer colorrectal metastásico | 0 | |
| 2019 | 5120 | Cáncer de próstata resistente a hormonas | 0 | |
| 2013 | 4976 | Cáncer de próstata resistente a hormonas | 0 | |
| 1995 | 3919 | Encefalopatía por contraste | 0 |
Historial de retiradas · 16 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 19 nov 2021 | III | Subpotent Drug | Lupin Pharmaceuticals Inc. |
| 1 oct 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct 2021 | II | cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. | Bayer Healthcare Pharmaceuticals Inc. |
| 1 oct 2021 | I | Chemical Contamination: presence of benzene | Bayer Healthcare Pharmaceuticals Inc. |
| 9 jul 2019 | I | Failed dissolution specifications : failed results at the 3-month stability time point. | Jubilant Cadista Pharmaceuticals, Inc. |
| 1 mar 2019 | II | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. | Apotex Inc. |
| 13 jun 2013 | III | Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point. | Bayer HealthCare Pharmaceuticals Inc. |
| 13 feb 2013 | II | Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) . | Watson Laboratories Inc |
| 22 ene 2013 | III | Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3. | Sandoz Incorporated |
| 8 may 2012 | II | Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product. | Bayer HealthCare 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 Bayer HealthCare Pharmaceuticals Inc. 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.