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Potential Contamination Leads to Recall of Atovaquone

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Bacillus cereus contamination in Atovaquone Oral Suspension, which treats AIDS-related pneumonia, was found during stability testing at a third-party lab.

AvKARE is voluntarily recalling one lot of Atovaquone Oral Suspension, USP 750 mg/5 mL because of the potential of Bacillus cereus contamination in the product found during stability testing at a third-party lab.

Bacillus cereus is a Gram-positive bacteria found in food and cause food poisoning. In patients who are immunocompromised, Bacillus cereus can result in life-threatening infections such as endocarditis and necrotizing soft tissue infections.

Atovaquone Oral Suspension is used to prevent and treat Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines. PCP is a serious infection caused by a fungus. According to the CDC, those with HIV/AIDS and those who take medications that weaken the immune system are most susceptible to PCP infection.

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

The Atovaquone subject to the recall was distributed between March 18, 2024 and March 21, 2024. The NDC number is 50268-086-12, and the affected lot number is AW0221A with an expiration date of August 2025.

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