| Category |
Press Release |
| Publish Date |
12/15/2020 |
| Author |
Paul Cochrane |
| Title |
Prescription Oral Rinse Recalled Due to Potential Bacterial Contamination |
| Introduction |
MPL Laboratories provides microbial and sterility testing services for pharmaceuticals, personal care products, consumer goods and cosmetics at its FDA registered, cGMP and ISO 17025 compliant testing facility. |
Sparta, NJ, December 15th, 2020
An Illinois company recently announced the recall of multiple lots of a prescription oral rinse used for the treatment of gingivitis. The recall notice was published by the U.S. Food and Drug Administration (FDA) and specifically mentions potential microbiological contamination from a type of bacteria known as Burkholderia lata.
According to the voluntary recall notice, “Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.”
This is not the first time Burkholderia lata has been associated with an oral rinse or mouth wash product. An article published by the U.S. National Library of Medicine describes an outbreak back in 2016 in Australia. In that case, eight intensive care patients from two hospitals were infected from a contaminated commercial mouthwash.
The scientists at MPL Laboratories deliver cGMP and ISO 17025 compliant microbiology testing in its FDA and DEA registered facility. MPL offers microbial testing of raw ingredients, finished products, production surfaces and water used for manufacturing. They also offer antimicrobial effectiveness testing, along with the microbial examination of nonsterile products.
With decades of experience, MPL’s scientists support the development and production of safe products that maintain a superior shelf life. They achieve this by providing cost-effective solutions that are available to manufacturers, importers, distributors, retailers, regulatory agencies, healthcare professionals and others.
To learn more about product testing and development or other sterility and microbial analysis 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 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. |
