FDA Recalls OTC Asthma Inhaler

The U.S. Food and Drug Administration (FDA) announced the recall recently of Nephron Pharmaceuticals’ over-the-counter bronchodilator and inhaler device due to misleading labeling and chocking concerns.

The agency said that the product’s label encourages consumers to use the product in an unapproved way.  The FDA also said that the device is unsafe due to the continuous battery-powered EZ Breathe atomizer that comes with the drug.  There is no evidence that asthmanefrin is safe or effective when used with the atomizer.

“[We] are not aware of the any other evidence establishing a product such as asthmanefrin being generally recognized as safe and effective when directed for use with a continuous atomizer such as the EZ Breathe Atomizer,” the FDA said in a statement.

The device has been marketed as a temporary relief of mild symptoms of intermittent asthma, including wheezing, tightness of chest and shortness of breath, the FDA said.

Nephron began selling the product in September 2012, and the FDA said it has received adverse event reports of chest pain, nausea/vomiting, increased blood pressure and possible hemoptysis associated with the use of asthmanefrin. The recall is noted in a Class I recall in a safety alert dated September 30.

Nephron Chief Scientific Officer Jerry Webb said in a statement that the manufacturer is in the process of redesigning the atomizer to prevent problems.

Our attorneys represent victims of dangerous medical devices and drugs. For more information about this or other defective medical drugs or devices, contact our experienced pharmaceutical drug and device attorneys by calling toll-free 888-841-9623 today.

Zoll & Kranz, LLC – Defective Medical Drug and Device Attorneys

ZK’s ‘Did You Know?’: In 2005, the FDA investigated Nephron for allegedly postmarketing adverse drug experience reporting requirements.