An injectable antibiotic created by B. Braun Medical Inc., the German medical and pharmaceutical company, was recalled last month due to the discovery of visible, floating particles found within vials of the drug. A sample of the recalled lot was found to contain visible specks of organic matter. While Braun did not specify what type of particulate matter was found in its product, it noted that metal, cotton fibers or hair may lead to life-threatening chronic or acute inflammatory reactions, like anaphylaxis. If used with a cardiac shunt, these particles could result in heart attack, stroke, respiratory failure, renal failure, or tissue necrosis. Other adverse events associated with this type of particulate matter are irritation of blood vessels and granulomata, especially in the lungs.
The U.S. Food and Drug Administration (FDA) posted the notice in order to warn health care professionals about the company’s recalled lot H3A7444 of its 1g Cefepime for Injection USP and DextroseInjection USP. The product is used as a cephalosporin antibacterial to treat infections caused by particular strains of designated microorganisms. The recalled lot expires January 2015. It was distributed nationwide to licensed distributors, hospitals and pharmacies in a Duplex single dose intravenous, plastic container with 24 units per case. The product was also distributed to customers between the dates of February 4 March 1, 2013. Thus far, according to the company, no reports of injuries or deaths have been reported to B. Braun after the usage of this recalled injectable.
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