MarcasUSA and Industria Farmacéutica Andromaco have issued a voluntary recall for four lots of Pasta De Lassar Andromaco Skin Protectant, an OTC skin product that was found to be contaminated.
In the recall notice posted by the FDA, an analysis by the regulatory agency of the 25% zinc oxide product found high levels of yeast, mold, and bacteria. Although the contaminated lot that was tested was not sold in the U.S., the discovery resulted in the recall of four lots that were distributed in the country.
To date, the company said it has not received any reports of adverse effects from use of the product.
Pasta de Lassar Andromaco is used for the treatment and prevention of diaper rash and other minor skin irritations.