Perfil del fabricante
Blue Echo Care LLC
Compañía farmacéutica2 productos registrados
2
productos registrados
1.439.995
notificaciones totales
14
retiradas registradas
18,2%
graves en total
Productos
Historial de retiradas · 11 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 26 ene 2022 | II | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. | CARDINAL HEALTHCARE |
| 17 nov 2021 | I | Temperature Abuse; temperature excursion during shipping | Sandoz Inc |
| 11 mar 2021 | II | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc |
| 11 mar 2021 | II | Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces. | Ferring Pharmaceuticals Inc |
| 2 feb 2021 | I | Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) | Apotex Corp. |
| 2 feb 2021 | I | Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength) | Apotex Corp. |
| 24 jul 2019 | II | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Colonia Care Pharmacy |
| 14 ago 2018 | III | Defective Delivery System: Water ingress through the lower water cup sensor of the device. | United Therapeutics Corp. |
| 12 feb 2016 | II | Lack of Assurance of Sterility | Walter's Pharmacy |
| 21 may 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Blue Echo Care 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.