American Regent, Inc.

Société pharmaceutique4 produits suivis

produits suivis

19 384

total des notifications

rappels enregistrés

63,4%

graves au total

Produits

affichage de 4 sur 4

Produit	Approuvé	Notifications ↓	Signal principal	Rappels
testosterone cypionate —	1978	8 660	Dépôt de produit	0
ferric carboxymaltose —	2013	4 574	Hypophosphatémie	1
ferric carboxymaltose injection —	—	4 574	Hypophosphatémie	0
droperidol —	1986	1 576	inflammation du lit de l'ongle	3

Historique des rappels · 11 enregistrés

Date	Classe	Motif	Fabricant
16 avr. 2026	III	Labeling: Missing Label	American Regent, Inc.
18 avr. 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 avr. 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 mai 2024	II	Lack of Assurance of Sterility.	American Regent, Inc.
18 juin 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 juin 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
24 févr. 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

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 American Regent, 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.