BIOCON PHARMA INC.

Société pharmaceutique2 produits suivis

produits suivis

27 936

total des notifications

111

rappels enregistrés

96,2%

graves au total

Produits

affichage de 2 sur 2

Produit	Approuvé	Notifications ↓	Signal principal	Rappels
norepinephrine —	1950	13 969	Choc cardiogénique	72
norepinephrine bitartrate —	1950	13 967	Choc cardiogénique	39

Historique des rappels · 47 enregistrés

Date	Classe	Motif	Fabricant
23 janv. 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 juil. 2023	II	Lack of Assurance of Sterility	SterRx, LLC
7 juil. 2023	II	Lack of Assurance of Sterility	SterRx, LLC
7 juil. 2023	II	Lack of Assurance of Sterility	SterRx, LLC
2 mai 2023	II	Lack of Assurance of Sterility	Apollo Care, LLC
28 avr. 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 avr. 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 avr. 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 mars 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 avr. 2022	II	CGMP Deviations	SCA Pharmaceuticals
14 mars 2022	II	Defective container	Athenex Pharma Solutions, LLC
14 mars 2022	II	Defective container	Athenex Pharma Solutions, LLC
14 mars 2022	II	Defective container	Athenex Pharma Solutions, LLC
14 févr. 2022	III	Subpotent drug	BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
31 déc. 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 juil. 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
16 déc. 2019	III	Subpotent Drug	Pharmedium Services, LLC
16 déc. 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 avr. 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 août 2018	I	Subpotent Drug: Product may not have the active ingredient present in the bag.	QuVa Pharma, Inc.
14 juin 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 juin 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 juin 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 juin 2018	II	Lack of Assurance of Sterility: Potential leakage of bags.	Avella of Deer Valley, Inc. Store 38
12 juin 2018	II	Lack of Assurance of Sterility: Potential leakage of bags.	Avella of Deer Valley, Inc. Store 38
12 juin 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 août 2017	II	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.	Pfizer Inc.
14 juil. 2017	II	Lack of Assurance of Sterility; product has the potential to leak.	SCA Pharmaceuticals
14 juil. 2017	II	Lack of Assurance of Sterility; product has the potential to leak.	SCA Pharmaceuticals
14 juil. 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
14 juil. 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
14 juil. 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
14 juil. 2017	II	Lack of Assurance of Sterility; product has the potential to leak.	SCA Pharmaceuticals
18 mai 2017	II	GMP Deviation; A foreign stopper was observed during packaging of a lot of product.	Hospira Inc., A Pfizer Company
22 févr. 2017	II	Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.	Advanced Pharma Inc.
20 avr. 2016	II	Lack of Assurance of Sterility	Pharmakon Pharmaceuticals, Inc.
17 avr. 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

Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.

Statut d'enregistrement

Certains produits de BIOCON PHARMA INC. ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.