Just weeks after receiving a close-out for a 2016 warning letter, adhesive patch maker Noven began recalling more than 130,000 boxes of its estradiol adhesive patches in two dose formulations.
According to an FDA Enforcement report, the class II recall was initiated because the patches failed to meet specifications for their sheer adhesive properties.
The patches were manufactured at Noven’s plant in Miami, Florida, a facility that has been issued FDA warning letters three times: in 2008, 2011 and then again in 2016.
Noven, a standalone operating subsidiary of Japan-based Hisamitsu Pharmaceuticals, received a close-out for the 2016 letter in April, just few weeks ahead of starting recalls.
The 2016 warning letter found Noven's operating procedures were not up to par. It said the FDA was concerned that the plant’s “unsound methods could be masking product failures.”
Before getting that warning, Noven recalled 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. The recall resulted in a nationwide shortage of the patches.