Sparta, NJ, December 6
th, 2019
A Florida company recently announced a worldwide recall of 21 lots of skin prepping lotion used for the enhancement of signal quality at electrode sites of healthcare patients. According to the company announcement, the tubes and single use cups of the products that are part of the recall have been found to be contaminated with
Burkholderia cepacia.
The U.S. Food & Drug Administration (FDA) has posted the recall information that impacts specific product
s lots that were distributed from September of 2017 to January of 2019 in hospitals in the U.S., Canada, Australia, Spain, England and the Netherlands. The company also stated that it had received one report of an adverse event related to the use of the product with a newborn.
Burkholderia cepacia is the name for a group or “complex” of bacteria that can be found in soil and water according to the Centers for Disease Control and Prevention (CDC). The bacteria typically poses little medical risk to healthy individuals, but the CDC does report that people who have certain health problems, like a weakened immune system or a chronic lung disease, particularly cystic fibrosis, may be more susceptible to infections.
B cepacia is a known cause of infections in hospitalized patients and the bacteria are often resistant to common antibiotics making potentially contaminated products used in a healthcare environment particularly concerning.
One company with decades of experience helping to identify sterility issues to prevent contaminated products from reaching consumers and the high costs associated with these types of recalls for manufacturers is MPL Laboratories. Their scientists and laboratory specialists operate an FDA and DEA registered facility that offers cGMP and ISO 17025 compliant
microbiology testing of personal care products, pharmaceuticals, cosmetics and other consumer goods. Testing services are available to manufacturers, packagers, importers, distributors, regulatory agencies and healthcare providers.
To learn more about this or other sterility and microbiological testing services provided 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 ISO/IEC 17025 accredited by PJLA, FDA and DEA registered, and NJDEP certified. MPL’s staff includes a PhD Diplomat of the American Board of Toxicology, M.S. and B.S. degreed microbiologists, and other dedicated scientists. The microbiology testing laboratory serves the pharmaceutical, medical device, 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 network of over 40 laboratories across the United States and Canada.
