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AvKARE, LLC 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 #AW0221A (NDC #50268-086-12, UPC #5026808612) with an expiration date of August 2025. The product was distributed between March 18, 2024 and March 21, 2024.
At this time, the Company has not received any 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.
References:
US Food and Drug Administration. AvKARE, LLC. issues voluntary nationwide recall of Atovaquone Oral Suspension, USP 750 mg/5 mL due to potential Bacillus cereus contamination. April 1, 2024. Accessed April 2, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due.
