Regulatory Focus™ > News Articles > Organic Particulates Lead to Recall for B.Braun Antibiotic

Organic Particulates Lead to Recall for B.Braun Antibiotic

Posted 16 October 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced that B. Braun Medical (B.Braun) is voluntarily initiating a recall of one lot of its injectable antibiotic Cefepime after "visible organic particulate matter" was observed in a reserve sample unit.

The drug, a combination of 1g Cefepime for Injection USP and Dextrose Injection USP, was first approved in May 2010 and comes in both 1g and 2g (approved in 2012) formulations.  It is indicated to "reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime for Injection USP and Dextrose Injection USP and other antibacterial drugs, Cefepime for Injection USP and Dextrose Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria."

However, the presence of particulate matter is particularly alarming as the drug is administered intravenously, meaning any contaminants like microorganisms would enter directly into the body, increasing the chance for potentially devastating infections.

Other non-microbial effects could be equally devastating to patients, FDA explained.

"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. B.Braun has not received any reports of adverse events related to this lot to date."

B.Braun did not identify the organic matter in a press statement, saying only that it traditionally includes objects like hair or cotton fibers. Injectable manufacturer Hospira, for example, recently recalled a lot of Aminosyn due to the presence of hair in at least one vial of the product.

Some precautionary measures can be used to reduce the chances of such particulates affecting patients. In the case of Hospira, the company said the use of an air eliminating filter would likely catch the hair. FDA has recommended the use of similar filters in the past in cases where a drug was in short supply but suffering from the presence of particulate-related manufacturing defects.

But for now, B.Braun has recommended that its customers cease using the product immediately and return the product to the company for a replacement.


B.Braun Recall Notice

FDA Statement


Tags: Recall

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