Labeling issues can sometimes lead to recalls because they pose serious health threats, and sometimes because a treatment for athlete’s foot is labeled as a treatment for jock itch.
GlaxoSmithKline’s consumer unit is recalling 462,732 bottles of Zeasorb AF miconazole nitrate 2% that it manufactured for its North Carolina-based Stiefel Laboratories. According to the FDA Enforcement report, some of the labels have incorrect NDC codes while some back labels incorrectly state “use for the cure of most jock itch" rather than "use for the cure of most athlete's foot."
The voluntary Class III recall actually began in October but was just recently posted by the FDA.
GlaxoSmithKline at CEO Andrew Witty’s direction has been putting more emphasis on its OTC products for several years now, a move he made because he realized there was growing pushback to high prices of prescription drugs. That has paid off for the drugmaker but not without a few stumbles. Last year it had to recall 3.9 million tubes of Biotene and Sensodyne toothpaste because they may have wood fragments in them. The toothpaste was manufactured for GSK by Oratech, a Utah-based contractor.