Herstellerprofil
Amgen, Inc
Pharmaunternehmen10 erfasste Produkte
10
erfasste Produkte
396.856
Meldungen insgesamt
35
dokumentierte Rückrufe
64,9%
schwerwiegend insgesamt
Produkte
10 von 10 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 2014 | 144.030 | Psoriasis-Arthropathie | 0 | |
| 2004 | 126.289 | Proteinurie | 27 | |
| 2001 | 53.035 | Pure Red Cell Aplasie | 0 | |
| 2006 | 14.905 | Metastasierter Darmkrebs | 1 | |
| 2008 | 14.658 | Abnormale Thrombozytenzahl | 1 | |
| 1989 | 13.801 | Nephrogene systemische Fibrose | 3 | |
| 2019 | 12.630 | Abnormale Knochendichte | 1 | |
| 2014 | 10.115 | Leukämische Infiltration extramedullär | 0 | |
| 2017 | 4.526 | Fehler bei der Verabreichung des abgefangenen Produkts | 2 | |
| 2017 | 2.867 | Shunt-Stenose | 0 |
Rückrufhistorie · 41 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 4. Juni 2026 | II | CGMP Deviations | Amgen, Inc. |
| 4. Juni 2026 | II | Presence of Foreign Substance. | Amgen, Inc. |
| 4. Juni 2026 | II | CGMP Deviations | Amgen, Inc. |
| 4. Juni 2026 | II | CGMP Deviations | Amgen, Inc. |
| 4. Juni 2026 | II | Presence of Foreign Substance. | Amgen, Inc. |
| 22. Sept. 2025 | II | Lack of assurance of sterility. | RC Outsourcing, LLC |
| 29. Aug. 2025 | II | Lack of Assurance of Sterility | Fagron Compounding Services |
| 21. Apr. 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. Okt. 2023 | II | Lack of Assurance of Sterility | Pine Pharmaceuticals, LLC |
| 27. März 2023 | III | Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. | Pine Pharmaceuticals, LLC |
| 2. Mai 2022 | II | Defective container: loose crimp defect, potential loss of container integrity. | Amgen, Inc. |
| 6. Dez. 2021 | II | Lack of Assurance of Sterility | Edge Pharma, LLC |
| 30. Aug. 2019 | II | Lack of assurance of sterility. | Pacifico National, Inc. dba AmEx Pharmacy |
| 30. Aug. 2019 | II | Lack of assurance of sterility. | Pacifico National, Inc. dba AmEx Pharmacy |
| 12. Juni 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 12. Juni 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 12. Juni 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| 3. Mai 2019 | II | Lack of assurance of sterility | Avella of Deer Valley, Inc. Store 38 |
| 19. Apr. 2019 | II | Defective Delivery System: difficult to express | Pacifico National, Inc. dba AmEx Pharmacy |
| 31. Okt. 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. Aug. 2017 | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| 15. Aug. 2017 | II | Lack of Assurance of Sterility. | Bella Pharmaceuticals, Inc. |
| 4. Aug. 2017 | II | Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials. | Amgen, Inc. |
| 15. Dez. 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. Jan. 2015 | I | Non-Sterility: Product tested positive for bacterial contamination. | Pacifico National, Inc. dba AmEx Pharmacy |
| 20. Jan. 2015 | I | Non-Sterility: Product tested positive for bacterial contamination. | Pacifico National, Inc. dba AmEx Pharmacy |
| 6. Okt. 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. Okt. 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. Aug. 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. Okt. 2010 | II | Presence of Particulate Matter: glass delamination | Physicians Total Care, Inc. |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Amgen, Inc sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.