Sparta, NJ, February 6, 2024
Last month, the U.S. Food & Drug Administration (FDA) posted information about the voluntary recall of one lot of an oral prescription drug for the treatment of tumors. The manufacturer has recalled the product due to microbial contamination identified as Penicillium brevicompactum.
According to the recall risk statement:
Although there is little data in the literature on human pathology caused by Penicillium brevicompactum, there are cases of invasive disease caused by similar Penicillium species, particularly in patients with underlying immunosuppression.
The impacted lot of the product was distributed to wholesale distributors and specialty pharmacies nationwide between January 3, 2023, and February 13, 2023. The manufacturer has notified those companies of the recall, and consumers who have the recalled product are advised to immediately stop using that particular lot of the drug.
Dedicated to helping prevent these types of costly product recalls that can also put consumers at risk are the scientists at MPL Laboratories. Their product testing experts identify contamination and sterility issues in a state-of-the-art facility that is FDA registered and DEA licensed. MPL Laboratories proudly offers cGMP and ISO 17025 compliant sterility and microbiology testing of pharmaceuticals, over-the-counter (OTC) medicines, cosmetics, personal care products and other consumer goods. These services are available to manufacturers, importers, distributors, regulatory agencies, healthcare providers and the public.
To learn more about microbial, sterility 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 ISO/IEC 17025 accredited by PJLA, FDA and DEA registered, and NJDEP certified. MPL’s staff includes a P.h.D, 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, 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 laboratories located across the United States and Canada.