An intravenous delivery system for a 1 gram dose of the antibiotic Cefepime for Injection USP and Dextrose Injection USP. / B. Braun Medical Inc.
WASHINGTON - U.S. government health officials are alerting doctors to the recall of an injectable antibiotic made by B. Braun Medical Inc., due to floating particles found in vials of the drug.
The Food and Drug Administration posted the notice Tuesday, warning health professionals that the company, a U.S. subsidiary of the German pharmaceutical firm B. Braun Melsungen, has recalled lot H3A7444 of its Cefepime for Injection USP and Dextrose Injection USP. Visible particles were found in a sample from the lot, including specs of metal, cotton fiber and hair.
The agency warned that using the drug could result in blood clots causing stroke, heart attack and other catastrophic problems.
The drug was distributed to hospitals, pharmacies and medical suppliers nationwide, according to the agency's release.
B.Braun is notifying its distributors and customers by written, return receipt letters and is arranging for return of all recalled product. Distributors and customers that have inventory of the 1g Cefepime for Injection USP and Dextrose Injection USP of lot H3A744 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. EST for instructions for returning the affected product and to arrange for replacement product.
Patients reporting any problems that may be related to the use of this product should be advised to 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 or by fax.
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.