Diaper rash cream recalled for high levels of yeast, mold, and bacteria

The U.S. Food and Drug Administration 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, California.

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 due to possible microbial contamination that 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 care 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.

FDA is not aware of reported adverse events associated with the use of these products. FDA asks health care professionals and consumers to report any adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program:

Complete and submit the report online at fda.gov/medwatch/report
Download and complete the form, then submit it via fax at 1-800-FDA-0178.

PASTA DE LASSAR ANDROMACO® brand of over-the-counter (OTC) skin protectant 25% zinc oxide is indicated for treatment and prevention of diaper rash and other minor skin irritations. The affected product includes that following lots and expiration dates:

 

The product is packaged in 60 gram tubes sold in individual boxes (UPC #851357003004, NDC #75940-111-60). The product was distributed Nationwide via wholesale, retail and internet.  MarcasUSA, LLC is notifying its distributors and customers by direct contact and is arranging for return of all recalled products. Consumers that have the product which is being recalled should stop using and return it to the place of purchase or discard it.