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FDA Deems the Recall of Nephron Pharmaceuticals' EZ Breathe Atomizer as a Class 1

Jun 4, 2013

The U.S. Food and Drug Administration (FDA) has deemed a recall initiated for Nephron Pharmaceuticals Corp.’s EZ Breathe Atomizer to be a Class 1.

The Class 1 designation for recalled pharmaceuticals and medical devices is the FDA’s most serious and means the agency believes using one of these products is likely to result in serious injuries or death.

This latest action was ordered at the end of April and includes EZ Breathe Atomizers distributed from August 2012 through April 2013. EZ Breathe Atomizers are used to deliver a spray liquid medication in an aerosol form. When the user pumps the device, they’re supposed to breathe in the spray, according to a recall statement posted by the FDA.

The EZ Breathe Atomizer is manufactured by Health & Life Co. and sold to Nephron Pharmaceuticals. The device is sold two ways: as part of the Asthmanefrin Starter Kit and on its own, packaged in a carton marked with the product’s name and model number EZ-100. Both formats are part of this recall.

Health & Life Co. ordered the recall after the company learned that a washer could become dislodged from the device. If that were to happen, a user could swallow the washer and choke on it, resulting in serious injuries or death, according to the FDA.

People who use devices targeted as Class 1 recalls should stop using them immediately to avoid the risk of serious injury or death.

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