Amgen, Inc

Société pharmaceutique10 produits suivis

produits suivis

396 856

total des notifications

rappels enregistrés

64,9%

graves au total

Produits

affichage de 10 sur 10

Produit	Approuvé	Notifications ↓	Signal principal	Rappels
apremilast —	2014	144 030	Arthropathie psoriasique	0
bevacizumab —	2004	126 289	Protéinurie	27
darbepoetin alfa —	2001	53 035	Aplasie érythrocytaire pure	0
panitumumab —	2006	14 905	cancer colorectal métastatique	1
romiplostim —	2008	14 658	Numération plaquettaire anormale	1
epoetin alfa —	1989	13 801	Fibrose systémique néphrogénique	3
romosozumab-aqqg —	2019	12 630	Densité osseuse anormale	1
blinatumomab —	2014	10 115	infiltration leucémique extramédullaire	0
bevacizumab-awwb —	2017	4 526	Erreur d'administration du produit interceptée	2
etelcalcetide —	2017	2 867	Sténose de shunt	0

Historique des rappels · 41 enregistrés

Date	Classe	Motif	Fabricant
4 juin 2026	II	CGMP Deviations	Amgen, Inc.
4 juin 2026	II	Presence of Foreign Substance.	Amgen, Inc.
4 juin 2026	II	CGMP Deviations	Amgen, Inc.
4 juin 2026	II	CGMP Deviations	Amgen, Inc.
4 juin 2026	II	Presence of Foreign Substance.	Amgen, Inc.
22 sept. 2025	II	Lack of assurance of sterility.	RC Outsourcing, LLC
29 août 2025	II	Lack of Assurance of Sterility	Fagron Compounding Services
21 avr. 2025	II	CGMP Deviations; potential temperature excursions due to transit delays	Mckesson Medical-Surgical Inc. Corporate Office
27 févr. 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 févr. 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 mars 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 déc. 2021	II	Lack of Assurance of Sterility	Edge Pharma, LLC
30 août 2019	II	Lack of assurance of sterility.	Pacifico National, Inc. dba AmEx Pharmacy
30 août 2019	II	Lack of assurance of sterility.	Pacifico National, Inc. dba AmEx Pharmacy
12 juin 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
12 juin 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
12 juin 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 avr. 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 août 2017	II	Lack of Assurance of Sterility.	Bella Pharmaceuticals, Inc.
15 août 2017	II	Lack of Assurance of Sterility.	Bella Pharmaceuticals, Inc.
4 août 2017	II	Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.	Amgen, Inc.
15 déc. 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 janv. 2015	I	Non-Sterility: Product tested positive for bacterial contamination.	Pacifico National, Inc. dba AmEx Pharmacy
20 janv. 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 août 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.

Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.

Statut d'enregistrement

Certains produits de Amgen, Inc ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.