B. Braun recalls product after organic particulate found

Another injected product is being recalled after particulate matter was discovered in a retained sample. This time, B. Braun Medical is voluntarily recalling one lot of an antibacterial infection treatment.

The company said in a release that a retained sample of cefepime for injection USP and dextrose injection USP was found to have visible organic particles. While Braun did not specify what it was, the company cautioned that particles like metals, fibers or hair can cause serious reactions if injected. Braun said it had not received any reports of adverse events.

The drug is packaged in a duplex single-dose intravenous, plastic container with 24 units in a case. It was shipped nationwide between Feb. 4 and March 1 of this year.

There have been a rash of recalls lately because of particulates in injected drugs, and hair and metal have figured into some of those. Hospira ($HSP) last month expanded a recall of bupivacaine injection because particles of stainless steel and iron oxide were found in some vials. Earlier, the company recalled a parenteral nutritional product after a human hair was found in a unit. Fresenius Kabi this year has recalled a couple of products because of glass particles found in vials, not an uncommon problem.

- here's the FDA release

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