BIOCON PHARMA INC.

Pharmaunternehmen2 erfasste Produkte

erfasste Produkte

27.936

Meldungen insgesamt

111

dokumentierte Rückrufe

96,2%

schwerwiegend insgesamt

Produkte

2 von 2 angezeigt

Produkt	Zugelassen	Meldungen ↓	Top-Signal	Rückrufe
norepinephrine —	1950	13.969	Kardiogener Schock	72
norepinephrine bitartrate —	1950	13.967	Kardiogener Schock	39

Rückrufhistorie · 47 dokumentiert

Datum	Klasse	Grund	Firma
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. Juli 2023	II	Lack of Assurance of Sterility	SterRx, LLC
7. Juli 2023	II	Lack of Assurance of Sterility	SterRx, LLC
7. Juli 2023	II	Lack of Assurance of Sterility	SterRx, LLC
2. Mai 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. März 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. März 2022	II	Defective container	Athenex Pharma Solutions, LLC
14. März 2022	II	Defective container	Athenex Pharma Solutions, LLC
14. März 2022	II	Defective container	Athenex Pharma Solutions, LLC
14. Feb. 2022	III	Subpotent drug	BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
31. Dez. 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. Juli 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
16. Dez. 2019	III	Subpotent Drug	Pharmedium Services, LLC
16. Dez. 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. 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. Juni 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. Juni 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. Juni 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. Juni 2018	II	Lack of Assurance of Sterility: Potential leakage of bags.	Avella of Deer Valley, Inc. Store 38
12. Juni 2018	II	Lack of Assurance of Sterility: Potential leakage of bags.	Avella of Deer Valley, Inc. Store 38
12. Juni 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. Juli 2017	II	Lack of Assurance of Sterility; product has the potential to leak.	SCA Pharmaceuticals
14. Juli 2017	II	Lack of Assurance of Sterility; product has the potential to leak.	SCA Pharmaceuticals
14. Juli 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
14. Juli 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
14. Juli 2017	II	Lack of Sterility Assurance.	Cantrell Drug Company
14. Juli 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. 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

Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.

Registrierungsstatus

Einige Produkte von BIOCON PHARMA INC. sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.