FDA MedWatch - Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA: Recall - Potential Contamination

Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA: Recall - Potential Contamination

AUDIENCE: Consumer, Pediatrics

ISSUE: MarcasUSA, LLC and Industria Farmacéutica Andromaco, S.A. de C.V. voluntarily recalled four lots of Pasta De Lassar Andromaco Skin Protectant, 25% zinc oxide to the retail level. FDA analysis of this product confirmed that Pasta De Lassar Andromaco is contaminated with high levels of yeast, mold, and bacteria. The specific lot associated to the positive findings was never sold in the US. However, due to the amount and type of contamination the remaining four lots in the US market are being recalled out of an abundance of caution.

Use of the contaminated product could result in an increased risk of infection.

BACKGROUND: 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.

RECOMMENDATION: Distributors and retailers that have Pasta De Lassar Andromaco which is being recalled should return to place of purchase (wholesaler or distributor).

Consumers with questions regarding this recall can contact MarcasUSA by phone at +1-800-428-9489 or by e-mail info@pastadelassar.com on Monday - Friday from 8am to 5pm, PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm603428.htm