Apotex Corp.

Compañía farmacéutica12 productos registrados

productos registrados

324.115

notificaciones totales

retiradas registradas

68,3%

graves en total

Productos

mostrando 12 de 12

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
carboplatin —	2004	122.601	Mielosupresión	8
paroxetine hydrochloride —	1992	89.618	exposición a fármacos durante el embarazo	4
tizanidine —	2002	40.362	Enfermedad renal crónica	0
atomoxetine hydrochloride —	2002	23.432	Blefaroespasmo	0
cefepime —	1996	15.696	Encefalopatía	19
cladribine —	1993	9240	Disminución del recuento de linfocitos	0
tetrabenazine —	2008	7266	Parkinsonismo	0
tasimelteon —	2014	5765	Insomnio intermedio	0
pentoxifylline —	1984	4243	Amaurosis fugax	1
fidaxomicin —	2011	2335	Infección por Clostridium difficile	1
alfuzosin hydrochloride —	2003	2290	Citólisis hepática	1
adefovir dipivoxil —	2002	1267	Osteomalacia hipofosfatémica	0

Historial de retiradas · 50 registradas

Fecha	Clase	Motivo	Empresa
8 abr 2026	II	Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.	Apotex Corp.
5 mar 2026	II	Lack of Assurance of Sterility	Apotex Corp.
5 sept 2025	II	Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns	Apotex Corp.
5 sept 2025	II	Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns	Apotex Corp.
28 may 2025	II	Lack of Assurance of Sterility	Apotex Corp.
28 may 2025	II	Lack of Assurance of Sterility	Apotex Corp.
28 may 2025	II	Lack of Assurance of Sterility	Apotex Corp.
28 may 2025	II	Defective Container: This recall is being initiated due to a leaking unit stored horizontally.	Apotex Corp.
9 feb 2024	II	CGMP Deviations: potential presence of Burkholderia cepacia complex	Apotex Corp.
1 nov 2023	II	Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine	Apotex Corp.
1 nov 2023	II	Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine	Apotex Corp.
1 nov 2023	II	Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine	Apotex Corp.
1 nov 2023	II	Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine	Apotex Corp.
15 may 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 may 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 may 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 may 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 may 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 may 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 may 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
26 abr 2023	II	Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.	Apotex Corp.
1 mar 2023	II	Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.	Apotex Corp.
27 dic 2022	II	Lack of sterility assurance	Sentara Infusion Services
7 jul 2022	II	Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.	Apotex Corp.
3 may 2022	III	Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.	Apotex Corp.
31 mar 2021	II	Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate	Apotex Corp.
2 feb 2021	I	Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)	Apotex Corp.
2 feb 2021	I	Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)	Apotex Corp.
11 nov 2020	II	Failed Dissolution Specifications: Out of specification for dissolution.	Apotex Corp.
12 jun 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
9 feb 2018	II	CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.	American Pharmaceutical Ingredients LLC
10 nov 2015	II	Lack of Assurance of Sterility	Walgreens Infusion Services
18 sept 2015	II	Lack of Assurance of Sterility: Product sterility cannot be guaranteed.	Sentara Enterprises
28 may 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured	Lincare, Inc.
28 may 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
28 may 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
18 mar 2015	I	Presence of Particulate Matter	Mylan Institutional LLC
14 nov 2014	II	Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 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
21 ago 2014	III	Failed Impurity/Degradation Specification; high out of specification for CAD II degradant	Apotex Corp.
15 may 2014	II	Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.	Franck's Lab Inc dba Trinity Care Solutions
15 may 2014	II	Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.	Franck's Lab Inc dba Trinity Care Solutions
15 may 2014	II	Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.	Franck's Lab Inc dba Trinity Care Solutions
18 abr 2014	III	Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.	Apotex Corp.
21 nov 2013	I	Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.	B. Braun Medical Inc
15 oct 2013	I	Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.	B. Braun Medical Inc
13 ago 2013	II	Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.	Teva Pharmaceuticals USA, Inc.
2 jul 2013	II	Labeling: Label Mixup; FIDAXOMICIN Tablet, 200 mg may be potentially mislabeled as BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: W003918, EXP: 6/28/2014.	Aidapak Services, LLC
10 may 2013	I	Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.	Apotex Corp.
18 mar 2013	I	Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.	Apotex Corp.
8 nov 2012	I	Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.	Hospira Inc.

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

Estado de registro

Algunos productos de Apotex Corp. 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.