American Regent, Inc.

Farmaceutisch bedrijf4 producten gevolgd

producten gevolgd

19.384

totaal meldingen

recalls geregistreerd

63,4%

ernstig algeheel

Producten

4 van 4 getoond

Product	Goedgekeurd	Meldingen ↓	Top signaal	Recalls
testosterone cypionate —	1978	8.660	productafzetting	0
ferric carboxymaltose —	2013	4.574	Hypofosfatemie	1
ferric carboxymaltose injection —	—	4.574	Hypofosfatemie	0
droperidol —	1986	1.576	ontsteking nagelbed	3

Recall-geschiedenis · 11 geregistreerd

Datum	Klasse	Reden	Bedrijf
16 apr 2026	III	Labeling: Missing Label	American Regent, Inc.
18 apr 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 apr 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 mei 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

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

Registratiestatus

Sommige producten van American Regent, 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.