B. Braun Medical Inc.

Compañía farmacéutica4 productos registrados

productos registrados

93.586

notificaciones totales

retiradas registradas

88,6%

graves en total

Productos

mostrando 4 de 4

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
calcium chloride —	1975	50.632	líquido de diálisis peritoneal turbio	19
cefepime hydrochloride —	1996	15.696	Encefalopatía	0
cefuroxime —	1983	15.483	Shock anafiláctico	8
cefazolin sodium —	1973	11.775	Shock anafiláctico	5

Historial de retiradas · 22 registradas

Fecha	Clase	Motivo	Empresa
2 oct 2023	II	Lack of Assurance of Sterility	Pine Pharmaceuticals, LLC
2 ago 2023	III	Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.	B. Braun Medical Inc.
5 jul 2023	II	Lack of assurance of sterility: bags have the potential to leak.	B. Braun Medical Inc.
10 feb 2023	II	Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.	B. Braun Medical Inc.
10 feb 2023	II	Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.	B. Braun Medical Inc.
7 oct 2022	II	Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.	Pharmacy Plus, Inc. dba Vital Care Compounder
9 may 2022	II	Lack of assurance of sterility.	Olympia Compounding Pharmacy dba Olympia Pharmacy
7 mar 2022	II	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding
6 dic 2021	II	Lack of Assurance of Sterility	Edge Pharma, LLC
13 ago 2021	II	Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
15 ene 2020	II	Lack of Assurance of Sterility	Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
12 ago 2019	II	Lack of Assurance of Sterility	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
19 jun 2019	II	Lack of Assurance of Sterility	RXQ Compounding LLC
19 feb 2019	II	Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.	Leiter's Enterprises, Inc.
23 ago 2018	II	Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper	Pacific Compounding Pharmacy & Consultations Inc
24 ene 2018	III	Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.	JCB Laboratories LLC
15 ago 2017	II	Lack of Assurance of Sterility.	Bella Pharmaceuticals, Inc.
18 nov 2016	II	Lack of Assurance of Sterility - the firm is recalling select sterile drug products.	Cantrell Drug Company
20 sept 2016	II	Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters	Leiter's Compounding
6 oct 2014	II	Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.	Oregon Compounding Centers, Inc. dba Creative Compounds
27 ago 2014	II	Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.	Martin Avenue Pharmacy, Inc.
31 may 2013	I	Non-Sterility: The firm's contract testing laboratory found sterility failures.	Abrams Royal Pharmacy

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

Estado de registro

Algunos productos de B. Braun Medical 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.