Bacterial Contamination Leads to Recall of Antifungal Drug

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Atovaquone Oral Suspension, which treats AIDS-related pneumonia, is being called because of the potential of Bacillus cereus contamination that could lead to life-threatening infections.

Camber Pharmaceuticals is recalling one lot of Atovaquone Oral Suspension 750mg/5mL because of the potential of Bacillus cereus contamination. Atovaquone Oral Suspension is indicated 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 the fungus Pneumocystis jirovecii. People most likely to get PCP have a medical condition that weakens their immune system such as HIV/AIDS.

Bacillus cereus is a foodborne pathogen that can cause vomiting and diarrhea. It is found in soik and food and can lead to food poisoning. In immunocompromised patients, there is a probability that contamination of Atovaquone Oral Suspension can result in life-threatening infections such as endocarditis and necrotizing soft tissue infections. To date, Camber has not received any reports of adverse events related to this recall. 

Atovaquone Oral Suspension was distributed nationwide to wholesalers, distributors, retail pharmacies, and mail order pharmacies. The impact lot is E220182 with an expiration date of December 2023. The NDC # is 31722-629-21 and the UPC # is 331722629218.

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