Perfil del fabricante
Amgen, Inc
Compañía farmacéutica10 productos registrados
10
productos registrados
396.856
notificaciones totales
35
retiradas registradas
64,9%
graves en total
Productos
mostrando 10 de 10
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 2014 | 144.030 | Artropatía psoriásica | 0 | |
| 2004 | 126.289 | Proteinuria | 27 | |
| 2001 | 53.035 | Aplasia pura de células rojas | 0 | |
| 2006 | 14.905 | cáncer colorrectal metastásico | 1 | |
| 2008 | 14.658 | Recuento de plaquetas anómalo | 1 | |
| 1989 | 13.801 | Fibrosis sistémica nefrogénica | 3 | |
| 2019 | 12.630 | Densidad ósea anómala | 1 | |
| 2014 | 10.115 | infiltración leucémica extramedular | 0 | |
| 2017 | 4526 | Error de administración de producto interceptado | 2 | |
| 2017 | 2867 | Estenosis de derivación | 0 |
Historial de retiradas · 41 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 4 jun 2026 | II | CGMP Deviations | Amgen, Inc. |
| 4 jun 2026 | II | Presence of Foreign Substance. | Amgen, Inc. |
| 4 jun 2026 | II | CGMP Deviations | Amgen, Inc. |
| 4 jun 2026 | II | CGMP Deviations | Amgen, Inc. |
| 4 jun 2026 | II | Presence of Foreign Substance. | Amgen, Inc. |
| 22 sept 2025 | II | Lack of assurance of sterility. | RC Outsourcing, LLC |
| 29 ago 2025 | II | Lack of Assurance of Sterility | Fagron Compounding Services |
| 21 abr 2025 | II | CGMP Deviations; potential temperature excursions due to transit delays | Mckesson Medical-Surgical Inc. Corporate Office |
| 27 feb 2025 | II | Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. | Amgen, Inc. |
| 27 feb 2025 | II | Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. | Amgen, Inc. |
| 6 nov 2024 | II | Lack of Sterility Assurance | Tailstorm Health INC |
| 2 oct 2023 | II | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC |
| 27 mar 2023 | III | Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. | Pine Pharmaceuticals, LLC |
| 2 may 2022 | II | Defective container: loose crimp defect, potential loss of container integrity. | Amgen, Inc. |
| 6 dic 2021 | II | Lack of Assurance of Sterility | Edge Pharma, LLC |
| 30 ago 2019 | II | Lack of assurance of sterility. | Pacifico National, Inc. dba AmEx Pharmacy |
| 30 ago 2019 | II | Lack of assurance of sterility. | Pacifico National, Inc. dba AmEx Pharmacy |
| 12 jun 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 12 jun 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 12 jun 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 3 may 2019 | II | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 |
| 19 abr 2019 | II | Defective Delivery System: difficult to express | Pacifico National, Inc. dba AmEx Pharmacy |
| 31 oct 2018 | II | Lack of Assurance of Sterility | Avella of Deer Valley, Inc. Store 38 |
| 13 sept 2017 | II | Presence of particulate matter: glass flakes identified as lamellae observed during a routine quality inspection. | Amgen, Inc. |
| 15 ago 2017 | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| 15 ago 2017 | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| 4 ago 2017 | II | Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials. | Amgen, Inc. |
| 15 dic 2016 | II | Lack of Assurance of Sterility: Potential cracks in glass vials | Amgen, Inc. |
| 4 nov 2015 | II | Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. | Pine Pharmaceuticals, LLC |
| 4 nov 2015 | II | Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. | Pine Pharmaceuticals, LLC |
| 4 nov 2015 | II | Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. | Pine Pharmaceuticals, LLC |
| 4 nov 2015 | II | Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use. | Pine Pharmaceuticals, LLC |
| 20 ene 2015 | I | Non-Sterility: Product tested positive for bacterial contamination. | Pacifico National, Inc. dba AmEx Pharmacy |
| 20 ene 2015 | I | Non-Sterility: Product tested positive for bacterial contamination. | Pacifico National, Inc. dba AmEx Pharmacy |
| 6 oct 2014 | II | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Oregon Compounding Centers, Inc. dba Creative Compounds |
| 19 oct 2013 | II | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Specialty Medicine Compounding Pharmacy |
| 17 sept 2013 | II | Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination. | Amgen, Inc. |
| 9 sept 2013 | II | Lack of Assurance of Sterility: Avella Specialty Pharmacy is recalling bevacizumab and vancomycin due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory. | Avella of Deer Valley, Inc. |
| 5 sept 2013 | II | Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate. | Fallon Wellness Pharmacy Llc |
| 26 ago 2013 | II | Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS/failed results were reported to customers as passing. Hence the sterility of the products cannot be assured. | Leiter's Pharmacy |
| 4 oct 2010 | II | Presence of Particulate Matter: glass delamination | Physicians Total Care, 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 Amgen, 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.