Perfil del fabricante
BluePoint Laboratories
Compañía farmacéutica4 productos registrados
4
productos registrados
122.013
notificaciones totales
13
retiradas registradas
79,9%
graves en total
Productos
mostrando 4 de 4
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1983 | 73.031 | Neutropenia febril | 5 | |
| 2006 | 36.591 | Derrame pleural | 1 | |
| 1979 | 7461 | Flatulencia vaginal | 4 | |
| 2006 | 4930 | Leucemia mieloide aguda recurrente | 3 |
Historial de retiradas · 11 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 2 jul 2024 | II | CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection. | SUN PHARMACEUTICAL INDUSTRIES INC |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 15 mar 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 10 feb 2021 | II | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products. | Teva Pharmaceuticals USA |
| 12 jun 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 12 jun 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 5 mar 2018 | III | Failed impurities/degradation specifications: Failure to water content and impurity | InvaGen Pharmaceuticals, Inc. |
| 22 dic 2016 | II | Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%) | Sandoz Incorporated |
| 12 feb 2015 | II | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance. | Health Innovations Pharmacy, Inc |
| 14 nov 2014 | II | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Attix Pharmaceuticals |
| 14 nov 2014 | II | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Attix Pharmaceuticals |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de BluePoint Laboratories 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.