GSK Label Mistakes Athlete’s Foot with Jock Itch

Labeling issues stating “use for the cure of most jock itch" rather than "use for the cure of most athlete's foot" leads to massive recall.


A recent FiercePharma article highlighted a labeling issue that lead to the recall of 462,732 bottles of Zeasorb AF miconazole nitrate2%. According to the FDA, some of the bottles had incorrect NDC codes, while others had the athlete’s foot/jock itch mix-up. The Class III recall began in October, but was just recently posted on the FDA’s Enforcement Report.

Due to high prices, GlaxoSmithKline’s CEO Andrew Witty has shifted focus from prescription drugs to OTC. The move has worked out well for the company despite a few speed bumps including last year’s recall of 3.9 million tubes of Biotene and Sensodyne toothpaste that contained wood fragments.

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