Sparta, New Jersey, July 5, 2023
The U.S. Food & Drug Administration (FDA) recently posted information about the recall of an atovaquone oral suspension by a pharmaceutical company that specializes in generic drugs and over-the-counter (OTC) medications. The oral suspension is being recalled due to potential contamination with a Gram-positive bacterium known as Bacillus cereus.
Atovaquone is an antimicrobial medication used for the prevention and treatment of Pneumocystis jirovecii pneumonia (PCP). One lot of the product, with a December 2023 expiration date, is part of the voluntary recall. The lot was distributed nationwide to wholesalers, distributors, retail pharmacies and mail order pharmacies. Consumers with the recalled product are advised to stop using it.
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 endocarditis and necrotizing soft tissue infections.
Working to help manufacturers and importers of pharmaceuticals and OTC medicines prevent the health risks associated with contaminated products reaching consumers, and the high costs created by a product recall, are the microbial testing experts at MPL Laboratories. Their scientists provide sterility and microbial testing for a broad spectrum of contaminants, including bacteria, yeasts and fungi. All testing takes place in MPL’s FDA registered and cGMP, ISO 17025 compliant laboratory to ensure the highest quality results.
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.
