Apotex Corp.

Pharmaunternehmen12 erfasste Produkte

erfasste Produkte

324.115

Meldungen insgesamt

dokumentierte Rückrufe

68,3%

schwerwiegend insgesamt

Produkte

12 von 12 angezeigt

Produkt	Zugelassen	Meldungen ↓	Top-Signal	Rückrufe
carboplatin —	2004	122.601	Knochenmarkhemmung	8
paroxetine hydrochloride —	1992	89.618	Medikamenteneinnahme während der Schwangerschaft	4
tizanidine —	2002	40.362	Chronische Nierenerkrankung	0
atomoxetine hydrochloride —	2002	23.432	Lidkrampf	0
cefepime —	1996	15.696	Enzephalopathie	19
cladribine —	1993	9.240	Abnahme der Lymphozytenzahl	0
tetrabenazine —	2008	7.266	Parkinsonismus	0
tasimelteon —	2014	5.765	Mittlere Schlaflosigkeit	0
pentoxifylline —	1984	4.243	Amaurosis fugax	1
fidaxomicin —	2011	2.335	Clostridium-difficile-Infektion	1
alfuzosin hydrochloride —	2003	2.290	Hepatische Zytolyse	1
adefovir dipivoxil —	2002	1.267	Hypophosphatämische Osteomalazie	0

Rückrufhistorie · 50 dokumentiert

Datum	Klasse	Grund	Firma
8. Apr. 2026	II	Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.	Apotex Corp.
5. März 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. Mai 2025	II	Lack of Assurance of Sterility	Apotex Corp.
28. Mai 2025	II	Lack of Assurance of Sterility	Apotex Corp.
28. Mai 2025	II	Lack of Assurance of Sterility	Apotex Corp.
28. Mai 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. Mai 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15. Mai 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15. Mai 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15. Mai 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15. Mai 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15. Mai 2023	II	Lack of Assurance of Sterility	Astral SteriTech Private Ltd.
15. Mai 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. März 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. Dez. 2022	II	Lack of sterility assurance	Sentara Infusion Services
7. Juli 2022	II	Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.	Apotex Corp.
3. Mai 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. März 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. Juni 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. Mai 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured	Lincare, Inc.
28. Mai 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
28. Mai 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
18. März 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. Mai 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. Mai 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. Mai 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. Juli 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. Mai 2013	I	Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.	Apotex Corp.
18. März 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.

Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.

Registrierungsstatus

Einige Produkte von Apotex Corp. sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.