B. Braun Medical is recalling one lot of Cefepime 1g for Injection and Dextrose Injection after it was found to contain visible organic particulate matter in a reserve sample unit.
Administration of particulate matter, including metals, and organic material (eg, cotton fiber, hair) may illicit inflammatory responses, and may be life threatening (eg, systemic inflammatory response syndrome, anaphylaxis). In addition, if a right to left cardiac shunt is present, the particulate may lead to arterial emboli and result in stroke, myocardial infarction, respiratory failure, renal/hepatic impairment, or tissue necrosis.
The affected product has lot # H3A744 (Exp. January 2015) and is packaged in a Duplex single-dose intravenous, plastic container in a 24-unit count case. B. Braun is notifying its distributors and customers, and is arranging for return of all recalled product.
Cefepime is a cephalosporin antibiotic indicated in the treatment of susceptible infections, including moderate-to-severe pneumonia, uncomplicated skin and skin structure infections, complicated and uncomplicated urinary tract infections (UTIs) including pyelonephritis, complicated intraabdominal in adults (w. metronidazole), and as empiric therapy in febrile neutropenia.
For more information call (800) 227-2862 or visit the FDA Safety Alert page.