Voluntary recall issued for MarcasUSA contaminated OTC skin protectant

(U.S. Food and Drug Administration)

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.

Free Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This webinar will discuss the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

Pasta de Lassar Andromaco is used for the treatment and prevention of diaper rash and other minor skin irritations.

Suggested Articles

The cleaning procedures are so poor at a Zydus Cadila plant in India that the FDA says a sampling found 10 different cross-contaminated products.

Mylan is the most recent drugmaker facing the FDA's ire over a tainted API that led to a global recall of "sartan"-based drugs last year.

Merck MSD's $1.2 billion production restructuring has fallen on a site in France, where more than 200 manufacturing and R&D jobs will be swept away.