Qualis Group LLC has recalled 888 units of Dionne Foot Rot Treatment, a topical antiseptic for animals, because the active ingredient, iodine, failed stability testing for being too low in concentration. The affected products include 8-fl. oz., 16-fl. oz. (1 Pint), and 32-fl. oz. (1 Quart) containers of the over-the-counter treatment containing Iodine 1% and Chloroxylenol 0.5%. These products were distributed across eight states: Illinois, Missouri, Washington, Oklahoma, North Carolina, Iowa, Tennessee, and South Dakota.
When the iodine level is lower than specified on the label, the antiseptic may not be effective at treating or preventing foot rot infections in animals. This can lead to a failure in treatment and the potential worsening of the animal's condition.
Drug product return and refund
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Sources: FDA iRES · Raw API Response