Orlando, FL-based Nephron Pharmaceuticals is recalling more than 80,000 cartons of its over-the-counter asthma treatment, which it says have discoloration issues.
Nephron, which two years ago got crosswise with the FDA over the asthma product, is recalling three lots, comprised of 32,490 cartons, of its Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator refills. It also is recalling 47,754 cartons of its starter kits, which include the refills and an atomizer.
The company's website says the OTC asthma product is FDA approved, but in 2013 it was not and the FDA issued a warning letter to the company saying so. It pointed out Nephron had never obtained an approved marketing application for the product. Further, it said the FDA final monograph for OTC bronchodilators did not include racepinephrine hydrochloride for use as a bronchodilator using a continuous atomizer such as the one Nephron was selling.
In addition the FDA said it had received "numerous FDA Adverse Event Reports" about the asthma product since it was introduced in September 2012. Those included reports of chest pain, nausea or vomiting, increased blood pressure, increased heart rate and possible hemoptysis. A week later it issued a warning to patients, doctors and caregivers saying many of the same things and pointing out the product at that point had never been evaluated by the FDA.
Nephron is not alone in recalling an asthma product this year. In May, India's Cipla voluntarily pulled a lot of its levalbuterol from the U.S. market after the asthma inhalation drug failed a test for a degradant. Shortly after, FDA inspectors visited the plant in Indore where Cipla made the product and came away with issues tied to that recall, saying Cipla had failed to figure out what was causing the degradation issues and whether the cause might be affecting other products.