Apotex Corp.

Farmaceutisch bedrijf12 producten gevolgd

producten gevolgd

324.115

totaal meldingen

recalls geregistreerd

68,3%

ernstig algeheel

Producten

12 van 12 getoond

Product	Goedgekeurd	Meldingen ↓	Top signaal	Recalls
carboplatin —	2004	122.601	onderdrukking van beenmergactiviteit	8
paroxetine hydrochloride —	1992	89.618	blootstelling aan medicijn tijdens zwangerschap	4
tizanidine —	2002	40.362	chronische nierziekte	0
atomoxetine hydrochloride —	2002	23.432	blefarospasme	0
cefepime —	1996	15.696	encefalopathie	19
cladribine —	1993	9.240	Afname aantal lymfocyten	0
tetrabenazine —	2008	7.266	parkinsonisme	0
tasimelteon —	2014	5.765	middelste slapeloosheid	0
pentoxifylline —	1984	4.243	amaurosis fugax	1
fidaxomicin —	2011	2.335	clostridium difficile infectie	1
alfuzosin hydrochloride —	2003	2.290	hepatische cytolyse	1
adefovir dipivoxil —	2002	1.267	hypofosfatemische osteomalacie	0

Recall-geschiedenis · 50 geregistreerd

Datum	Klasse	Reden	Bedrijf
8 apr 2026	II	Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.	Apotex Corp.
5 mrt 2026	II	Lack of Assurance of Sterility	Apotex Corp.
5 sep 2025	II	Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns	Apotex Corp.
5 sep 2025	II	Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns	Apotex Corp.
28 mei 2025	II	Lack of Assurance of Sterility	Apotex Corp.
28 mei 2025	II	Lack of Assurance of Sterility	Apotex Corp.
28 mei 2025	II	Lack of Assurance of Sterility	Apotex Corp.
28 mei 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 mei 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 mei 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 mei 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 mei 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 mei 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 mei 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15 mei 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
26 apr 2023	II	Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.	Apotex Corp.
1 mrt 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 dec 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 mei 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 mrt 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 sep 2015	II	Lack of Assurance of Sterility: Product sterility cannot be guaranteed.	Sentara Enterprises
28 mei 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured	Lincare, Inc.
28 mei 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
28 mei 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
18 mrt 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 aug 2014	III	Failed Impurity/Degradation Specification; high out of specification for CAD II degradant	Apotex Corp.
15 mei 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 mei 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 mei 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 apr 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 okt 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 aug 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 mei 2013	I	Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.	Apotex Corp.
18 mrt 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.

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Registratiestatus

Sommige producten van Apotex Corp. 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.