B. Braun Medical Issues Recall of Cefepime, Dextrose Injection LotOct 16, 2013
B. Braun Medical Inc. (B. Braun) has issued a consumer recall of one lot of 1g Cefepime for Injection USP and Dextrose Injection USP. This is due to findings that reveal the presence of visible organic particulate matter in a reserve sample unit. No reports of adverse events related to this lot have been received to date, the company says.
“Visible particulate matter, including metals, and organic material such as cotton fibers or hair, may also illicit inflammatory responses, both chronic and acute, and may be life threatening,” the company notes in a recall alert. “If a right to left cardiac shunt is present, the particulate may lead to arterial emboli and result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function or tissue necrosis. Other adverse effects associated with intravenous injection of particulate matter include foreign body granulomata, particularly in the lungs, and local irritation of blood vessels.”
The product is used as a cephalosporin antibacterial to treat infections caused by susceptible strains of designated microorganisms. The product is packaged in a Duplex single-dose intravenous plastic container, with 24 units per case. The affected lot, H3A744, which expires in January 2015, was distributed nationwide to licensed distributors, hospitals and pharmacies, and distributed to customers between the dates of February 4, 2013 and March 1, 2013, the company says.
B. Braun is notifying its distributors and customers via written, return-receipt letters and is arranging for the return of all recalled product. Distributors and customers that have inventory from the recalled lot should discontinue use immediately and contact B. Braun’s customer support department at 1-800-227-2862, Monday through Friday, 8 a.m. to 7 p.m. Eastern Standard Time for instructions for returning the affected product and to arrange for replacement product.
Patients reporting problems related to use of this product should contact a physician and report all issues to B. Braun at 1-800-854-6851. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program, either online, by regular mail (use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm; mail to address on the pre-addressed form), or by fax, 1-800-FDA-0178.