BETHESDA, MD 16 Oct 2013—FDA announced yesterday that B. Braun Medical Inc. has recalled
one lot of cefepime in the Duplex drug delivery system after finding visible organic particulates in a retained sample of the product.
The recalled lot, H3A744, contains 1 g of cefepime for injection plus dextrose for injection packaged in Duplex conainers.
The medication and its diluent occupy separate compartments in the container until it is activated for use.
The recalled lot is labeled with an expiration date of January 2015 and was shipped nationwide this year from February 4 to March 1.
Anyone with the recalled product on hand should immediately cease using it and contact the company at 800-227-2862, Monday through Friday, 8 a.m. to 7 p.m. Eastern Time, for information about returning and replacing the product.
According to the company, no adverse events related to the recall have been reported. Patients who have problems that may be related to the use of the recalled product should contact their health care provider and report the problem to B. Braun at 800-854-6851.