BIOCON PHARMA INC.

Farmaceutisch bedrijf2 producten gevolgd

producten gevolgd

27.936

totaal meldingen

111

recalls geregistreerd

96,2%

ernstig algeheel

Producten

2 van 2 getoond

Product	Goedgekeurd	Meldingen ↓	Top signaal	Recalls
norepinephrine —	1950	13.969	cardiogene shock	72
norepinephrine bitartrate —	1950	13.967	cardiogene shock	39

Recall-geschiedenis · 47 geregistreerd

Datum	Klasse	Reden	Bedrijf
23 jan 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 mei 2023	II	Lack of Assurance of Sterility	Apollo Care, LLC
28 apr 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 apr 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 apr 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 mrt 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 apr 2022	II	CGMP Deviations	SCA Pharmaceuticals
14 mrt 2022	II	Defective container	Athenex Pharma Solutions, LLC
14 mrt 2022	II	Defective container	Athenex Pharma Solutions, LLC
14 mrt 2022	II	Defective container	Athenex Pharma Solutions, LLC
14 feb 2022	III	Subpotent drug	BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
31 dec 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 dec 2019	III	Subpotent Drug	Pharmedium Services, LLC
16 dec 2019	III	Subpotent Drug	Pharmedium Services, LLC
12 sep 2019	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
12 sep 2019	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
12 apr 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 aug 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 okt 2017	II	Lack of Assurance of Sterility.	Banner Pharmacy Services, LLC
10 okt 2017	II	Lack of Assurance of Sterility.	Banner Pharmacy Services, LLC
22 aug 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 mei 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 apr 2016	II	Lack of Assurance of Sterility	Pharmakon Pharmaceuticals, Inc.
17 apr 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

Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.

Registratiestatus

Sommige producten van BIOCON PHARMA INC. 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.