BIOCON PHARMA INC.

Pharmaceutical company2 products tracked

products tracked

27,936

total reports

111

recalls on record

96.2%

serious overall

Products

showing 2 of 2

Product	Approved	Reports ↓	Top signal	Recalls
norepinephrine —	1950	13,969	Cardiogenic shock	72
norepinephrine bitartrate —	1950	13,967	Cardiogenic shock	39

Recall history · 47 on record

Date	Class	Reason	Firm
Jan 23, 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
Jul 7, 2023	II	Lack of Assurance of Sterility	SterRx, LLC
Jul 7, 2023	II	Lack of Assurance of Sterility	SterRx, LLC
Jul 7, 2023	II	Lack of Assurance of Sterility	SterRx, LLC
May 2, 2023	II	Lack of Assurance of Sterility	Apollo Care, LLC
Apr 28, 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.
Apr 28, 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.
Apr 28, 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.
Mar 29, 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
Apr 25, 2022	II	CGMP Deviations	SCA Pharmaceuticals
Mar 14, 2022	II	Defective container	Athenex Pharma Solutions, LLC
Mar 14, 2022	II	Defective container	Athenex Pharma Solutions, LLC
Mar 14, 2022	II	Defective container	Athenex Pharma Solutions, LLC
Feb 14, 2022	III	Subpotent drug	BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Dec 31, 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
Nov 12, 2021	II	Lack of Assurance of Sterility	SterRx, LLC
Nov 12, 2021	II	Lack of Assurance of Sterility	SterRx, LLC
Nov 12, 2021	II	Lack of Assurance of Sterility	SterRx, LLC
Nov 12, 2021	II	Lack of Assurance of Sterility	SterRx, LLC
Nov 12, 2021	II	Lack of Assurance of Sterility	SterRx, LLC
Jul 29, 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
Dec 16, 2019	III	Subpotent Drug	Pharmedium Services, LLC
Dec 16, 2019	III	Subpotent Drug	Pharmedium Services, LLC
Sep 12, 2019	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
Sep 12, 2019	II	Lack of Assurance of Sterility	KRS Global Biotechnology, Inc
Apr 12, 2019	II	Lack of sterility assurance.	CMC Enterprise Pharmacy
Nov 21, 2018	III	Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride	QuVa Pharma, Inc.
Aug 27, 2018	I	Subpotent Drug: Product may not have the active ingredient present in the bag.	QuVa Pharma, Inc.
Jun 14, 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
Jun 14, 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
Jun 14, 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
Jun 12, 2018	II	Lack of Assurance of Sterility: Potential leakage of bags.	Avella of Deer Valley, Inc. Store 38
Jun 12, 2018	II	Lack of Assurance of Sterility: Potential leakage of bags.	Avella of Deer Valley, Inc. Store 38
Jun 12, 2018	II	Lack of Assurance of Sterility: Potential leakage of bags.	Avella of Deer Valley, Inc. Store 38
Oct 10, 2017	II	Lack of Assurance of Sterility.	Banner Pharmacy Services, LLC
Oct 10, 2017	II	Lack of Assurance of Sterility.	Banner Pharmacy Services, LLC
Aug 22, 2017	II	Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.	Pfizer Inc.
Jul 14, 2017	II	Lack of Assurance of Sterility; product has the potential to leak.	SCA Pharmaceuticals
Jul 14, 2017	II	Lack of Assurance of Sterility; product has the potential to leak.	SCA Pharmaceuticals
Jul 14, 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
Jul 14, 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
Jul 14, 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
Jul 14, 2017	II	Lack of Assurance of Sterility; product has the potential to leak.	SCA Pharmaceuticals
May 18, 2017	II	GMP Deviation; A foreign stopper was observed during packaging of a lot of product.	Hospira Inc., A Pfizer Company
Feb 22, 2017	II	Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.	Advanced Pharma Inc.
Apr 20, 2016	II	Lack of Assurance of Sterility	Pharmakon Pharmaceuticals, Inc.
Apr 17, 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 = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from BIOCON PHARMA INC. are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.