AvKARE, LLC. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5 mL Due to Potential Bacillus Cereus Contamination

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AvKARE, LLC. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5 mL Due to Potential Bacillus Cereus Contamination

FOR IMMEDIATE RELEASE – 3/29/2024 –AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab.

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. To date, AvKARE has not received any reports of adverse events related to this recall.

Atovaquone Oral Suspension, USP is 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.