Noven has been recalling tens of thousands of boxes of its Daytrana patches from the market because of issues over peeling away a protective liner to deliver the ADHD drug. More recently, the drugmaker has warned customers that the patches are out of stock and won’t be readily available until August.
Noven began recalling more than 125,000 of the methylphenidate transdermal patches in July 2015, but according to the most recent FDA Enforcement report, Noven began retrieving another 22,223 boxes of the patches in different strengths, a recall the FDA only this week classified and posted on its website. According to reports, Noven began the recalls last year after an FDA inspection resulted in a Form 483 with 13 observations.
The patches were recalled because they were out of spec for their mechanical peel force and z-statistic value. The drugmaker explained that relates to the patient’s or caregiver’s ability to remove the release liner from the patch adhesive prior to administration. The patches, which were manufactured at Noven’s facility in Miami, FL, are approved for children and adolescents.
Then in April, Noven announced that there was “a shortage of all strengths of Daytrana that is expected to last until third quarter of this year.”
Noven, a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical, did not respond to a request for comment. The company has twice received FDA warning letters, one in 2008 and one in 2011, a couple of years after Hisamitsu bought the company for $430 million.
Noven is not the only drugmaker in the midst of a recall of an ADHD drug. Allergan ($AGN) has been recalling more than 50 lots, consisting of nearly 600,000 bottles, of its copy of the ADHD drug Adderall.