EZ Breathe Atomizers, sold by Nephron Pharmaceuticals Corporation, have been recalled, according to the U.S. Food and Drug Administration (FDA), which has deemed this recall a Class I.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the recalled product will cause serious, adverse health consequences or death.
The recalled EZ Breathe Atomizers were manufactured from May 2012 to October 2012 and were distributed from August 2012 to April 2013. Product Codes and Lot Numbers may be accessed at the Nephron Pharmaceuticals Corporation’s EZ Breathe Atomizer information page here.
The EZ Breathe Atomizer was also sold by Nephron Pharmaceuticals Corporation as an individual device in a carton labeled EZ Breathe Atomizer, Model #EZ-100. The device includes a part called the “medication cup” (as a replacement part) and was distributed by Nephron Pharmaceuticals Corporation.
The EZ Breathe Atomizer Recall Customer Care Center may be reached, toll-free, at 1.855.413.8920 from 8:00 a.m. to 5:00 p.m., Eastern Time.
Customers should stop using any EZ Breathe Atomizer units contained in the Asthmanefrin Starter Kits with the affected lot numbers, as well as EZ Breathe Atomizer units that were sold individually.
The EZ Breathe Atomizer is a device that is intended to spray liquid medication in aerosol form into the air that a person will breathe. The EZ Breathe Atomizer recall was implemented after Health & Life Co., Ltd. was made aware of a manufacturing defect that could cause the washer (“Plate A”) to become dislodged from the EZ Breathe Atomizer. Should this occur, users may accidentally swallow the washer or choke on it, which can lead to serious adverse health consequences or death.
The EZ Breathe Atomizer is manufactured by Health & Life Co., Ltd. and sold to Nephron Pharmaceuticals Corporation. Nephron Pharmaceuticals Corporation distributes the EZ Breathe Atomizer for sale and use in the Asthmanefrin Starter Kit. Nephron Pharmaceuticals Corporation initiated the EZ Breathe Atomizer on behalf of Health & Life Co., Ltd.