AvPAK

Compañía farmacéutica2 productos registrados

productos registrados

22.105

notificaciones totales

retiradas registradas

63,2%

graves en total

Productos

mostrando 2 de 2

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
isosorbide dinitrate —	1968	19.613	Ataque isquémico transitorio	8
artificial tears —	—	2492	Oftalmopatía endocrina	20

Historial de retiradas · 26 registradas

Fecha	Clase	Motivo	Empresa
25 mar 2026	II	Lack of Assurance of Sterility	Preferred Pharmaceuticals, Inc.
3 mar 2026	II	Lack of Assurance of Sterility	K.C. Pharmaceuticals, Inc
3 mar 2026	II	Lack of Assurance of Sterility	K.C. Pharmaceuticals, Inc
23 abr 2025	II	cGMP deviations and lack of assurance of sterility.	BRS Analytical Services, LLC
13 jun 2023	II	CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.	K.C. Pharmaceuticals, Inc
26 abr 2023	II	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Akorn, Inc.
30 ene 2023	I	Non-Sterility: FDA analysis found unopened products to have bacterial contamination.	Global Pharma Healthcare Private Limited
30 ene 2023	I	Non-Sterility: FDA analysis found unopened products to have bacterial contamination.	Global Pharma Healthcare Private Limited
30 ene 2023	II	CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.	Global Pharma Healthcare Private Limited
30 ene 2023	II	CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.	Global Pharma Healthcare Private Limited
13 oct 2022	II	CGMP Deviations:	Akorn, Inc.
13 oct 2022	II	CGMP Deviations:	Akorn, Inc.
2 ago 2021	II	Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.	Akorn, Inc.
2 nov 2018	II	Cross Contamination with Other Products	Sandoz Inc
2 nov 2018	II	Cross Contamination with Other Products	Sandoz Inc
2 nov 2018	II	Cross Contamination with Other Products	Sandoz Inc
2 nov 2018	II	Cross Contamination with Other Products	Sandoz Inc
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
2 jul 2013	II	Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.	Aidapak Services, LLC
2 jul 2013	II	Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014; PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014.	Aidapak Services, LLC
2 jul 2013	II	Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD22845_10, EXP: 5/2/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: AD32757_10, EXP: 5/14/2014.	Aidapak Services, LLC
25 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 because 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
25 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 because 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
25 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 because 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
25 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 because 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
25 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 because 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 AvPAK 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.