American Regent, Inc.

Compañía farmacéutica4 productos registrados

productos registrados

19.384

notificaciones totales

retiradas registradas

63,4%

graves en total

Productos

mostrando 4 de 4

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
testosterone cypionate —	1978	8660	depósito del producto	0
ferric carboxymaltose —	2013	4574	Hipofosfatemia	1
ferric carboxymaltose injection —	—	4574	Hipofosfatemia	0
droperidol —	1986	1576	inflamación del lecho ungueal	3

Historial de retiradas · 11 registradas

Fecha	Clase	Motivo	Empresa
16 abr 2026	III	Labeling: Missing Label	American Regent, Inc.
18 abr 2025	II	Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.	American Regent, Inc.
18 abr 2025	II	Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.	American Regent, Inc.
11 nov 2024	II	Presence of Particulate Matter: Potential for glass delamination from the vials.	American Regent, Inc.
11 nov 2024	II	Presence of Particulate Matter: Potential for glass delamination from the vials.	American Regent, Inc.
11 nov 2024	II	Presence of Particulate Matter: Potential for glass delamination from the vials.	American Regent, Inc.
14 may 2024	II	Lack of Assurance of Sterility.	American Regent, Inc.
18 jun 2019	II	Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.	Premier Pharmacy Labs Inc
12 jun 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
24 feb 2015	II	Presence of particulate.	SCA Pharmaceuticals
14 nov 2014	II	Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.	Attix Pharmaceuticals

Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.

Estado de registro

Algunos productos de American Regent, 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.