Medication Monitor

Generic Name (Trade Name—Company)
April 4, 2018

Diaper rash ointment

(Pasta De Lassar Andromaco zinc oxide diaper rash treatment—Industria Farmac√©utica Andr√≥maco)
FDA warns of high levels of microbial contamination in diaper rash treatment

FDA is alerting consumers of a voluntary recall of a topical drug product, Pasta De Lassar Andromaco zinc oxide diaper rash treatment, made by Industria Farmacéutica Andrómaco, Toluca, Mexico, and distributed by MarcasUSA LLC, El Segundo, CA.

FDA laboratory analysis confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. This is especially concerning because Pasta De Lassar Adromoca is labeled for use to relieve diaper rash, where irritated skin can become infected. Therefore, consumers and caregivers should not use this product because possible microbial contamination may cause infections.

Consumers who have Pasta De Lassar Andromaco should stop using it and dispose of it immediately. Consumers also should contact their doctor or health professional if they have concerns or if they develop an infection following the use of topical drug products made by Industria Farmacéutica.

Pasta De Lassar Andromaco and other topical drug products made by Industria Farmacéutica are available online and in retail stores. Additionally, the company donated its Pasta De Lassar Andromaco product to a charity in California.