B. Braun Medical Inc. is recalling one lot of its Cefepime for Injection and Dextrose Injection over the medication containing visible organic particulate matter, the U.S. Food and Drug Administration (FDA) just announced.
The recall involves one lot of B.Braun 1-gram Cefepime for Injection USP and Dextrose Injection USP (Lot H3A744, catalog 3193-11), at the consumer level. The 1g Cefepime for Injection USP and Dextrose Injection USP contains visible organic particulate matter in a reserve sample unit. To date, B.Braun has not received any reports of adverse events related to this lot.
Visible particulate matter, including metals, and organic material such as cotton fibers or hair, may cause inflammatory responses—chronic and acute—in patients and may be life threatening, leading to, for example, systemic inflammatory response syndrome (SIRS and/or anaphylaxis). Also, if a right to left cardiac shunt is present in the patient’s body, the particulate released from the injectable 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 tied to intravenous injection of particulate matter may also include foreign body granulomata, particularly in the lungs, and local blood vessel irritation.
Cefepime for Injection and Dextrose Injection is used as a cephalosporin antibacterial that is indicated for the treatment of infections caused by susceptible strains of designated microorganisms. The recalled Cefepime for Injection and Dextrose Injection is packaged in a DUPLEX® single dose intravenous, plastic container with 24 units per case. The affected lot, H3A744, which expires January 2015, was distributed nationwide to licensed distributors, hospitals and pharmacies, and was also distributed to customers, between February 4, 2013 and March 1, 2013.
B.Braun is contacting its distributors and customers in writing with return receipt letters, and is also arranging for return of all of the recalled product. Distributors and customers with inventory of the 1g Cefepime for Injection USP and Dextrose Injection USP of lot H3A744 should discontinue its use immediately and contact B.Braun’s Customer Support Department, toll-free, at 1.800.227.2862, Monday through Friday, from 8:00 a.m. to 7:00 p.m., Eastern Standard Time (EST), for instructions on how to return the recalled product and to arrange for replacement product.
Patients reporting any problems that may be related to the use of this product should contact a physician and report any 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 or by fax: Online go to www.fda.gov/medwatch/report.htm. By regular mail or fax, use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm and either mail to the address on the pre-addressed form or fax the completed form to 1.800.FDA.0178.