Sparta, NJ, November 14th, 2017
Early this year, the U.S. Food & Drug Administration (FDA) posted information about a pharmaceutical company out of Texas that voluntarily announced a product recall of two different over-the-counter medicines. At the time of the notice, the pharmaceutical company disclosed no known reports of adverse events associated with the recalled medicines, but it was advising consumers to immediately stop using the products.
The company initiated the recall due to potential contamination with Burkholderia cepacia. According to the Centers for Disease Control and Prevention (CDC), B. cepacia is the name for a group or “complex” of bacteria that can be found in soil and water, and transmission has been associated with contaminated medicines and devices in the past.
Typically, B. cepacia poses little medical risk to healthy people. However, the CDC reports that people who have certain health problems, like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections. Due to this fact, B cepacia is a known cause of infections in some hospitalized patients and unfortunately the bacteria are often resistant to common antibiotics.
To help identify sterility issues and prevent contaminated products from reaching consumers, MPL Laboratories’ FDA registered and DEA licensed facility offers cGMP and ISO 17025 compliant sterility and microbiology testing of pharmaceuticals, medical devices, cosmetics and personal care products. These analytical services are available to pharmaceutical companies, manufacturers, regulatory agencies and healthcare providers in the United States, Canada and across the globe.
To learn more about this or other pharmaceutical, cosmetic or personal care product testing services provided by MPL Laboratories, please visit www.MPLLaboratories.com, call (800) 548-1874 or email patty@marypaullabs.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.
