Cefepime and Dextrose Injection Recall Issued Due to Particulate Matter

Particulate matter contamination has led to the recall of one lot of Cefepime and Dextrose injection fluid, due to a potential risk that the injections could cause severe and life threatening health consequences.  

A Cefepime and Dextrose injection fluid recall was announced by the FDA on October 15, after the manufacturer found visible organic particles had entered the fluid during production. No injuries or reports of illnesses have been reported to date.

Cefepime and Dextrose injection is an antibiotic combination used to fight off microorganism infection such as fungus and other strong forms of bacteria.

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The recall includes 1g Cefepime for injection USP and Dextrose injection USP with lot number H3A744 and catalog number 3193-11. The affected lot was packaged in a DUPLEX single dose intravenous plastic container with 24 units in each case and has expiration date January 2015.

The injections were manufactured by B. Braun Medical Inc., and distributed to licensed distributors, hospitals, pharmacies, and customers between February 4, 2013 and March 1, 2013.

Use of the contaminated injections may cause several health consequences such as phlebitis, weakened immune systems, and both chronic and acute inflammatory responses. The risk to the consumer is heightened if the debris travels throughout the body posing a risk of inflammation in the lungs, respiratory failure, renal failure, and even strokes if a left cardiac shunt is present.

B. Braun has started to notify all known distributors and customers by mail with a return receipt letter to be filled out and returned along with all remaining product. Customers should stop issuing or taking the affected injection fluid immediately and contact B. Brauns Customer Support Department at 1-800-227-2862 for instructions on how to receive a replacement product.

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