FDA WARNING_LETTER - Nephron Pharmaceuticals Corp.

The FDA issued a Warning Letter to Nephron Pharmaceuticals Corporation regarding their OTC drug product Asthmanefrin (racepinephrine hydrochloride) and the co-packaged EZ Breathe Atomizer.

Asthmanefrin is deemed an unapproved new drug because its labeled use with a continuous atomizer like the EZ Breathe Atomizer is not generally recognized as safe and effective under the OTC bronchodilator final monograph (21 CFR Part 341). Marketing this product without an FDA-approved application violates sections 301(d) and 505(a) of the Act.

The EZ Breathe Atomizer is adulterated under section 501(f)(1)(B) for lacking an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) because it was introduced into interstate commerce for uses different from legally marketed devices (21 CFR 868.5640) without a required premarket notification (510(k)). Evidence includes its packaging with Asthmanefrin, specific usage instructions, and accessories for direct patient delivery.

Furthermore, Asthmanefrin is misbranded under Section 502(a) due to the false or misleading claim "Alternative to Primatene Mist CFC Inhaler," as it is an unapproved drug not proven comparable.

The FDA expressed significant safety concerns, citing numerous adverse event