BIOCON PHARMA INC.

Compañía farmacéutica2 productos registrados

productos registrados

27.936

notificaciones totales

111

retiradas registradas

96,2%

graves en total

Productos

mostrando 2 de 2

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
norepinephrine —	1950	13.969	Shock cardiogénico	72
norepinephrine bitartrate —	1950	13.967	Shock cardiogénico	39

Historial de retiradas · 47 registradas

Fecha	Clase	Motivo	Empresa
23 ene 2024	II	Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.	Baxter Healthcare Corporation
7 jul 2023	II	Lack of Assurance of Sterility	SterRx, LLC
7 jul 2023	II	Lack of Assurance of Sterility	SterRx, LLC
7 jul 2023	II	Lack of Assurance of Sterility	SterRx, LLC
2 may 2023	II	Lack of Assurance of Sterility	Apollo Care, LLC
28 abr 2023	II	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.	Central Admixture Pharmacy Services, Inc.
28 abr 2023	II	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.	Central Admixture Pharmacy Services, Inc.
28 abr 2023	II	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.	Central Admixture Pharmacy Services, Inc.
29 mar 2023	III	Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.	SUN PHARMACEUTICAL INDUSTRIES INC
25 abr 2022	II	CGMP Deviations	SCA Pharmaceuticals
14 mar 2022	II	Defective container	Athenex Pharma Solutions, LLC
14 mar 2022	II	Defective container	Athenex Pharma Solutions, LLC
14 mar 2022	II	Defective container	Athenex Pharma Solutions, LLC
14 feb 2022	III	Subpotent drug	BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
31 dic 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
12 nov 2021	II	Lack of Assurance of Sterility	SterRx, LLC
12 nov 2021	II	Lack of Assurance of Sterility	SterRx, LLC
12 nov 2021	II	Lack of Assurance of Sterility	SterRx, LLC
12 nov 2021	II	Lack of Assurance of Sterility	SterRx, LLC
12 nov 2021	II	Lack of Assurance of Sterility	SterRx, LLC
29 jul 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
16 dic 2019	III	Subpotent Drug	Pharmedium Services, LLC
16 dic 2019	III	Subpotent Drug	Pharmedium Services, LLC
12 sept 2019	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
12 sept 2019	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
12 abr 2019	II	Lack of sterility assurance.	CMC Enterprise Pharmacy
21 nov 2018	III	Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride	QuVa Pharma, Inc.
27 ago 2018	I	Subpotent Drug: Product may not have the active ingredient present in the bag.	QuVa Pharma, Inc.
14 jun 2018	II	Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.	SCA Pharmaceuticals, LLC
14 jun 2018	II	Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.	SCA Pharmaceuticals, LLC
14 jun 2018	II	Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.	SCA Pharmaceuticals, LLC
12 jun 2018	II	Lack of Assurance of Sterility: Potential leakage of bags.	Avella of Deer Valley, Inc. Store 38
12 jun 2018	II	Lack of Assurance of Sterility: Potential leakage of bags.	Avella of Deer Valley, Inc. Store 38
12 jun 2018	II	Lack of Assurance of Sterility: Potential leakage of bags.	Avella of Deer Valley, Inc. Store 38
10 oct 2017	II	Lack of Assurance of Sterility.	Banner Pharmacy Services, LLC
10 oct 2017	II	Lack of Assurance of Sterility.	Banner Pharmacy Services, LLC
22 ago 2017	II	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.	Pfizer Inc.
14 jul 2017	II	Lack of Assurance of Sterility; product has the potential to leak.	SCA Pharmaceuticals
14 jul 2017	II	Lack of Assurance of Sterility; product has the potential to leak.	SCA Pharmaceuticals
14 jul 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
14 jul 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
14 jul 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
14 jul 2017	II	Lack of Assurance of Sterility; product has the potential to leak.	SCA Pharmaceuticals
18 may 2017	II	GMP Deviation; A foreign stopper was observed during packaging of a lot of product.	Hospira Inc., A Pfizer Company
22 feb 2017	II	Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.	Advanced Pharma Inc.
20 abr 2016	II	Lack of Assurance of Sterility	Pharmakon Pharmaceuticals, Inc.
17 abr 2013	II	Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production.	Unique Pharmaceutical, Ltd

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

Estado de registro

Algunos productos de BIOCON PHARMA 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.