FDA Announces Injectable Antibiotic Recall

The US Food and Drug Administration (FDA) has announced the recall of one lot of 1g Cefepime for Injection USP and Dextrose Injection USP (Lot H3A744, catalog 3193-11) produced by B. Braun Medical Inc.

The agency reported that a sample of the injectable drug contained “a visible organic particulate matter in a reserve sample unit.”

In a release, the FDA said that “visible particulate matter, including metals, and organic material such as cotton fibers or hair, may illicit inflammatory responses, both chronic and acute, and may be life threatening (e.g. systemic inflammatory response syndrome (SIRS and/or anaphylaxis).”

The drug is reportedly used to treat antibacterial infections. The affected drugs expire in January 2015, and were circulated nationwide to licensed distributors, hospitals and pharmacies between the dates of February 4, 2013 and March 1, 2013. B. Braun has said that it will be arranging for the return of all recalled products.

It should be noted that although this recall indicates that something could be wrong with this particular lot of drugs, it also indicates that there may be an issue with the manufacturer when it comes to clean work environments.

Last year, the New England Compounding Pharmacy, Inc. d/b/a New England Compounding Center (NECC) recall that lead to the deadly outbreak of fungal meningitis that swept the country was allegedly resulted from tainted injections, which may have come from unsanitary work and manufacturing conditions.

Our attorneys represent victims of dangerous medical devices and drugs, many of which have been recalled due to safety issues. For more information about this or other defective medical drugs or devices, contact our experienced pharmaceutical drug and device attorneys by calling toll-free (888)-841-9623. today.