Perfil del fabricante
Bausch & Lomb Incorporated
Compañía farmacéutica4 productos registrados
4
productos registrados
73.260
notificaciones totales
23
retiradas registradas
47,8%
graves en total
Productos
mostrando 4 de 4
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 2001 | 27.882 | aumento de la presión intraocular | 9 | |
| 2001 | 27.882 | aumento de la presión intraocular | 10 | |
| 2016 | 16.017 | Reacción en el lugar de la instilación | 4 | |
| — | 1479 | Vasculopatía coroidea polipoidea | 0 |
Historial de retiradas · 14 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 5 mar 2026 | II | Lack of Assurance of Sterility | Apotex Corp. |
| 5 sept 2025 | II | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns | Apotex Corp. |
| 28 may 2025 | II | Lack of Assurance of Sterility | Apotex Corp. |
| 1 mar 2023 | II | Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility. | Apotex Corp. |
| 10 may 2022 | III | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation |
| 10 may 2022 | III | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation |
| 10 may 2022 | III | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation |
| 10 may 2022 | III | Failed Impurities/Degradation Specifications. | Novartis Pharmaceuticals Corporation |
| 4 jun 2020 | III | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC |
| 4 jun 2020 | III | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC |
| 4 jun 2020 | III | Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life. | SOMERSET THERAPEUTICS LLC |
| 19 mar 2019 | II | cGMP Deviations | Allergan Sales, LLC |
| 19 oct 2017 | III | Failed Impurities/Degradation Specifications. | Allergan Sales, LLC |
| 23 jun 2017 | II | Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier | ImprimisRx CA, Inc., dba ImprimisRx |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Bausch & Lomb Incorporated 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.