B. Braun Medical Inc.

Pharmaunternehmen4 erfasste Produkte

erfasste Produkte

93.586

Meldungen insgesamt

dokumentierte Rückrufe

88,6%

schwerwiegend insgesamt

Produkte

4 von 4 angezeigt

Produkt	Zugelassen	Meldungen ↓	Top-Signal	Rückrufe
calcium chloride —	1975	50.632	Trübe Peritonealflüssigkeit	19
cefepime hydrochloride —	1996	15.696	Enzephalopathie	0
cefuroxime —	1983	15.483	Anaphylaktischer Schock	8
cefazolin sodium —	1973	11.775	Anaphylaktischer Schock	5

Rückrufhistorie · 22 dokumentiert

Datum	Klasse	Grund	Firma
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. Juli 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. Mai 2022	II	Lack of assurance of sterility.	Olympia Compounding Pharmacy dba Olympia Pharmacy
7. März 2022	II	Lack of Assurance of Sterility	TMC Acquisition LLC dba Tailor Made Compounding
6. Dez. 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. Juni 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. Sept. 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. Mai 2013	I	Non-Sterility: The firm's contract testing laboratory found sterility failures.	Abrams Royal Pharmacy

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

Registrierungsstatus

Einige Produkte von B. Braun Medical 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.