Sparta, New Jersey, February 2, 2023
In December, the U.S. Food & Drug Administration (FDA) posted information about the recall of one lot of single-use packets of a burn cream. The burn cream, sold in boxes of 10 and also packaged in multiple brands of first aid kits, is designed for use as an over-the-counter first aid treatment for minor burns.
The product is being recalled because FDA analysis found the product to be contaminated with bacteria known
Bacillus licheniformis and
Bacillus sonorensis. The recall notice warns that in immunocompromised patients, the topical use of the contaminated burn cream could potentially result in severe or life-threatening adverse events such as bacteremia, sepsis and peritonitis. It also cautions that in non-immunocompromised patients, the use of the defective product may result in infectious complications, such as skin infections that are less severe and more readily responsive to treatment.
The product was distributed nationwide to retailers from March 4, 2022 through December 12, 2022. Consumers are advised to stop using the recalled lot of the burn cream and to discard it.
Dedicated to helping companies identify and prevent contamination issues that could put patients and consumers at risk, as well as the high costs associated with product recalls, are the scientists at MPL Laboratories. Their FDA and DEA registered facility offers cGMP and ISO 17025 compliant microbial testing of personal care products, OTC medicines, pharmaceuticals, cosmetics and a wide range of other consumer goods.
MPL Laboratories provides testing of raw ingredients, manufacturing surfaces, final products and packaging. These and other services are available to manufacturers, importers, distributors, retailers, regulatory agencies and health care providers.
To learn more about product testing services offered by MPL Laboratories, please visit
www.MPLLaboratories.com, call (800) 548-1874 or email
info@MPLLaboratories.com.
About MPL Laboratories
MPL Laboratories (formerly Marypaul Laboratories) was founded in 1985 as a full-service microbiology laboratory. It is cGMP compliant, FDA and DEA registered, ISO/IEC 17025 accredited by PJLA, and NJDEP certified. MPL’s staff includes M.S. and B.S. degreed microbiologists and other dedicated scientists. The microbiology testing laboratory serves the pharmaceutical, cosmetic, personal care and food industries. MPL aims to provide its clients with high quality, reliable test data in a timely manner. The laboratory is part of the EMSL Analytical, Inc. network of laboratories across the United States and Canada.
