Sparta, NJ, October 31, 2024
The U.S. Food & Drug Administration (FDA) posted information recently about the recall of an Atovaquone Oral Suspension by a pharmaceutical company that was produced for them by another drug product manufacturer. The oral suspension is being recalled due to potential contamination with a Gram-positive bacterium known as
Cohnella.
Atovaquone is an antimicrobial medication used for the prevention and treatment of
Pneumocystis jirovecii pneumonia (PCP). One batch of the product, which was distributed between December 21, 2023 and June 20
th of this year, is part of the voluntary recall. The batch was distributed nationwide to wholesalers and retailers. Consumers with the recalled product are advised to stop using it and should contact their physician or healthcare provider if they have experienced any problems that may be related to using the drug.
According to the published recall risk statement:
In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as inflammation of the heart and permanent damage to soft tissue.
Working to help manufacturers and importers of pharmaceutical and over the counter (OTC) medicines prevent the health risks associated with contaminated products reaching patients, and the high costs associated with a product recall, are the microbial testing experts at MPL Laboratories. Their scientists provide compliant testing for a broad spectrum of microbial contaminants that includes bacteria, yeasts, and molds. All testing takes place in MPL’s FDA registered and cGMP, ISO 17025 compliant laboratory to ensure the highest quality results.
To learn more about microbial or sterility testing of pharmaceuticals, OTC medicines, personal care products, cosmetics, or other goods, 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. MPL’s staff includes a Ph.D. Diplomat of the American Board of Toxicology, M.S. and B.S. degreed microbiologists, along with other dedicated scientific personnel. The microbiology testing laboratory serves the pharmaceutical, cosmetic, and personal care product industries. MPL strives to provide its clients with reliable, defensible test data delivered in a timely manner. The laboratory is part of the EMSL Analytical network of laboratories across the United States and Canada.
