A company that is a supplier to pharmacists recently initiated a voluntary nationwide recall of two lots of a flavored suspending agent used for compounding drugs to the hospital, pharmacy and distributor level. The affected lots are potentially contaminated with Burkholderia gladioli.
According to the company announcement, posted by the U.S. Food & Drug Administration (FDA): Burkholderia gladioli is an opportunistic pathogen most commonly affecting patients with respiratory disease. Patients with compromised immune systems such as those with Cystic Fibrosis are at higher risk. Burkholderia gladioli also can cause complications after transplants. Exposure to contaminated product could lead to adverse events, which could be severe for at-risk individuals.
The manufacturer had reportedly received multiple complaints regarding an undesirable smell associated with the product. Fortunately, at the time of the recall posting, the company had not received any reports of adverse events related to the product. Those with the recalled lots of the suspending agent have been told to immediately discontinue use or distribution of it.
Working to help prevent these types of costly product recalls that can put consumers at risk are the dedicated scientists at MPL Laboratories. Their testing experts identify contamination issues in their FDA and DEA registered facility. They offer cGMP and ISO 17025 compliant microbiology testing of pharmaceuticals, OTC medicines, cosmetics, personal care products and other consumer goods. These services are available to manufacturers, importers, distributors, regulatory agencies and healthcare providers.
To learn more about microbial or other product 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 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.
— WebWireID290571 —