FDA alerts consumers of a nationwide voluntary recall of topical drug products made by Industria Farmacéutica Andrómaco due to contamination
FDA lab confirmed high levels of microbial contamination in company’s Pasta De Lassar Andromaco diaper rash treatment
[3/30/2018] 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 www.fda.gov/medwatch/report.htm
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.