Alembic Pharmaceuticals Inc.

Compañía farmacéutica10 productos registrados

productos registrados

744.315

notificaciones totales

retiradas registradas

78,3%

graves en total

Productos

mostrando 10 de 10

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
methotrexate —	1953	484.893	Sinovitis	14
paclitaxel —	1992	95.870	Mielosupresión	7
candesartan —	1998	61.711	Sibilancias	12
candesartan cilexetil —	1998	28.000	hiperpotasemia	12
sumatriptan succinate —	1992	25.906	Migraña	7
rivastigmine —	2000	18.798	Fenómeno de encendido y apagado	3
itraconazole —	1992	11.466	Infección por Aspergillus	7
bosutinib —	2012	8855	Leucemia mieloide crónica	0
asenapine —	2009	8632	Anosognosia	3
pivmecillinam —	2024	184	Hipersensibilidad documentada al producto administrado	0

Historial de retiradas · 45 registradas

Fecha	Clase	Motivo	Empresa
1 ago 2024	III	Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.	Amneal Pharmaceuticals, LLC
22 sept 2023	III	Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.	West-Ward Columbus Inc
22 dic 2022	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
26 ene 2022	II	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.	CARDINAL HEALTHCARE
6 dic 2021	II	Lack of Assurance of Sterility	Edge Pharma, LLC
13 sept 2021	III	Failed Impurities/Degradation Specifications; out of specification for Related Compound	Viatris
19 abr 2021	III	Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent	SigmaPharm Laboratories LLC
19 abr 2021	III	Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent	SigmaPharm Laboratories LLC
1 abr 2021	II	Failed Dissolution Specifications	Jubilant Cadista Pharmaceuticals, Inc.
22 mar 2021	III	Failed Impurities/Degradation Specifications	Macleods Pharma Usa Inc
15 mar 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
2 oct 2020	III	Out-of-specification organic impurity results obtained during routine stability testing.	Mylan Pharmaceuticals Inc.
19 mar 2020	II	Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.	Edge Pharma, LLC
12 jun 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
12 jun 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
12 jun 2019	II	Lack of Assurance of Sterility	Infusion Options, Inc.
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
18 may 2017	II	Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets	Forest Laboratories, LLC
6 mar 2017	III	Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.	Dr. Reddy's Laboratories, Inc.
17 may 2016	II	Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.	Well Care Compounding Pharmacy
17 may 2016	II	Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.	Well Care Compounding Pharmacy
26 ene 2016	III	Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)	Amerisource Health Services
31 dic 2015	III	Failed Impurities/Degradation Specifications; 9 month stability timepoint	Sandoz Inc
3 ago 2015	II	Failed Dissolution Specifications	Dr. Reddy's Laboratories, 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 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
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
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
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
16 oct 2014	III	Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.	Apotex Inc.
16 oct 2014	III	Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.	Apotex Inc.
16 oct 2014	III	Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.	Apotex Inc.
16 oct 2014	III	Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.	Apotex Inc.
2 oct 2014	III	Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.	Sandoz, Inc
21 ago 2014	III	Failed Impurity/Degradation Specification; high out of specification for CAD II degradant	Apotex Corp.
1 nov 2013	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Natures Pharmacy & Compounding Center
2 jul 2013	II	Labeling: Label Mixup: CANDESARTAN CILEXETIL, Tablet, 16 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC 65862063830, Pedigree: W003649, EXP: 6/25/2014.	Aidapak Services, LLC
2 jul 2013	II	Labeling: Label Mixup; ITRACONAZOLE, Capsule, 100 mg may be potentially mislabeled as FAMCICLOVIR, Tablet, 500 mg, NDC 00093811956, Pedigree: AD54549_4, EXP: 5/20/2014.	Aidapak Services, LLC
20 may 2013	I	Presence of Particulate Matter: Found during examination of retention samples.	Sandoz Incorporated
2 may 2013	II	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.	THE COMPOUNDING SHOP, INC.
20 mar 2013	II	Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes	Clinical Specialties Compounding Pharmacy
27 jun 2012	II	The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.	Hospira Inc.
27 jun 2012	II	The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.	Hospira Inc.
21 may 2012	II	Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.	Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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

Estado de registro

Algunos productos de Alembic Pharmaceuticals Inc. 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.