Amgen, Inc

Farmaceutisch bedrijf10 producten gevolgd

producten gevolgd

396.856

totaal meldingen

recalls geregistreerd

64,9%

ernstig algeheel

Producten

10 van 10 getoond

Product	Goedgekeurd	Meldingen ↓	Top signaal	Recalls
apremilast —	2014	144.030	psoriatische artropathie	0
bevacizumab —	2004	126.289	Eiwit in urine	27
darbepoetin alfa —	2001	53.035	Pure rode cel aplasie	0
panitumumab —	2006	14.905	Gemetastaseerde colorectale kanker	1
romiplostim —	2008	14.658	Bloedplaatjesaantal afwijkend	1
epoetin alfa —	1989	13.801	nefrogene systemische fibrose	3
romosozumab-aqqg —	2019	12.630	Abnormale botdichtheid	1
blinatumomab —	2014	10.115	extramedullaire leukemische infiltratie	0
bevacizumab-awwb —	2017	4.526	fout bij toediening van product (onderschept)	2
etelcalcetide —	2017	2.867	vernauwing van de shunt	0

Recall-geschiedenis · 41 geregistreerd

Datum	Klasse	Reden	Bedrijf
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 sep 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 mrt 2023	III	Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.	Pine Pharmaceuticals, LLC
2 mei 2022	II	Defective container: loose crimp defect, potential loss of container integrity.	Amgen, Inc.
6 dec 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 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 mei 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 sep 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 dec 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 sep 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 sep 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 sep 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.

Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.

Registratiestatus

Sommige producten van Amgen, Inc zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.