B. Braun Medical Inc.

Farmaceutisch bedrijf4 producten gevolgd

producten gevolgd

93.586

totaal meldingen

recalls geregistreerd

88,6%

ernstig algeheel

Producten

4 van 4 getoond

Product	Goedgekeurd	Meldingen ↓	Top signaal	Recalls
calcium chloride —	1975	50.632	Troebel peritoneumvocht	19
cefepime hydrochloride —	1996	15.696	encefalopathie	0
cefuroxime —	1983	15.483	Anafylactische shock	8
cefazolin sodium —	1973	11.775	Anafylactische shock	5

Recall-geschiedenis · 22 geregistreerd

Datum	Klasse	Reden	Bedrijf
2 okt 2023	II	Lack of Assurance of Sterility	Pine Pharmaceuticals, LLC
2 aug 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 okt 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 mei 2022	II	Lack of assurance of sterility.	Olympia Compounding Pharmacy dba Olympia Pharmacy
7 mrt 2022	II	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding
6 dec 2021	II	Lack of Assurance of Sterility	Edge Pharma, LLC
13 aug 2021	II	Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns	First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
15 jan 2020	II	Lack of Assurance of Sterility	Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
12 aug 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 aug 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 jan 2018	III	Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.	JCB Laboratories LLC
15 aug 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 sep 2016	II	Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters	Leiter's Compounding
6 okt 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 aug 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 mei 2013	I	Non-Sterility: The firm's contract testing laboratory found sterility failures.	Abrams Royal Pharmacy

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

Registratiestatus

Sommige producten van B. Braun Medical 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.