Camber Pharmaceuticals is recalling 1 lot of Atovaquone Oral Suspension, USP 750mg/5mL due to the potential for microbial contamination with Bacillus cereus, a gram positive, anaerobic bacterium.
Atovaquone Oral Suspension is a quinone antimicrobial drug indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole.
The recall involves Lot #E220182 with an expiration date of December 2023. At this time, the Company has not received and reports of adverse events related to this recall. In immunocompromised individuals, the use of contaminated product could potentially lead to life-threatening infections such as endocarditis and necrotizing soft tissue infections.
Adverse reactions related to this recall should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program.
This article originally appeared on MPR
Camber Pharmaceuticals, Inc. issues voluntary nationwide recall of Atovaquone Oral Suspension, USP 750mg/5mL due to potential Bacillus cereus contamination in the product. News release. March 14, 2023. https://www.prnewswire.com/news-releases/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-of-atovaquone-oral-suspension-usp-750mg5ml-due-to-potential-bacillus-cereus-contamination-in-the-product-301771846.html.