Perfil del fabricante
Baxter Healthcare Company
Compañía farmacéutica3 productos registrados
3
productos registrados
197.972
notificaciones totales
34
retiradas registradas
96,3%
graves en total
Productos
mostrando 3 de 3
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| — | 172.252 | Neutropenia febril | 0 | |
| 1987 | 20.887 | Linfoma difuso de células B grandes recurrente | 3 | |
| 1964 | 4833 | Apendicolito | 31 |
Historial de retiradas · 24 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 8 mar 2022 | II | Super Potent and Failed Reconstitution Time | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mar 2022 | II | Product found to be Sub Potent or Exceeded reconstitution time | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mar 2022 | III | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mar 2022 | II | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 8 mar 2022 | III | Super Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| 20 nov 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 20 nov 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 20 nov 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 20 nov 2020 | II | CGMP deviations: Lack of potency testing. | Complete Pharmacy and Medical Solutions, LLC. |
| 12 jun 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 10 sept 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sept 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sept 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sept 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 10 sept 2018 | II | Lack of Assurance of Sterility | Pharm D Solutions, LLC |
| 15 ago 2017 | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| 8 mar 2016 | II | Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin. | Hospira Inc. |
| 2 jun 2015 | II | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | The Compounding Pharmacy of America |
| 27 ago 2014 | II | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. | Martin Avenue Pharmacy, Inc. |
| 27 ago 2014 | II | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. | Martin Avenue Pharmacy, Inc. |
| 12 may 2014 | II | Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products. | John W Hollis Inc |
| 13 sept 2013 | II | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. | AmeriSource Bergen |
| 13 sept 2013 | II | Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. | AmeriSource Bergen |
| 28 may 2013 | II | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. | Main Street Family Pharmacy, 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 Baxter Healthcare Company 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.