Second Company Recalls Prescription Oral Rinse Due to Potential Bacterial Contamination

In late October, an Illinois company announced the recall of multiple lots of a prescription oral rinse used for the treatment of gingivitis. This recall notice was followed by another in November by a Massachusetts firm that sourced and repackaged the chlorhexidine gluconate oral rinse acquired from the company out of Illinois, but sold the medicine under its own brand name with different lot numbers and expiration dates.

Both recall notices were published by the U.S. Food and Drug Administration (FDA) and specifically mention potential microbiological contamination from a bacteria known as Burkholderia lata. The recall notices both state that, “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.”

MPL delivers cGMP and ISO 17025 compliant microbiology testing in its FDA and DEA registered facility. Their scientists offer microbial testing of raw ingredients, finished products, production surfaces and water used for manufacturing. MPL also delivers antimicrobial effectiveness testing, along with the microbial examination of nonsterile products.

MPL’s scientists, with decades of industry expertise, support the development and production of safe products that maintain a superior shelf life. This is achieved through cost-effective and rapid testing solutions. These services are available to manufacturers, repackaging companies, importers, distributors, retailers, regulatory agencies and healthcare professionals.

To learn more about product testing and development services or other sterility and microbial analysis 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 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 over 45 laboratories across the United States and Canada.

Contact Information

Joseph Frasca

Senior Vice President of Marketing

MPL Laboratories

(1) 856-303-2503

Contact via E-mail