Contaminated Drug Recalled: Atovaquone Oral Suspension Poses Deadly Infection Risk

A recent discovery has led to the recall of Atovaquone Oral Suspension, a drug primarily used to treat a form of pneumonia. The pharmaceutical company, AvKARE, took this action after third-party testing revealed a potential Bacillus cereus contamination in one specific lot of the medicine.

Potential Health Risks

The risk statement in the AvKARE recall notice emphasizes the severe potential consequences of using the contaminated Atovaquone Oral Suspension, especially for the immunocompromised population. The statement highlights a significant risk of developing disseminated, life-threatening infections such as endocarditis and necrotizing soft tissue infections. Endocarditis is characterized by inflammation of the inner lining of the heart’s chambers and valves, while necrotizing soft tissue infections are serious conditions that necessitate immediate intervention to prevent the destruction of skin, muscle, and other soft tissues.

Recalled Lot Details

The specific lot that has been recalled is identified as No. AW0221A, with an expiration date of 08/2025. This lot corresponds to Atovaquone Oral Suspension, USP 750mg/5mL, bearing the NDC and UPC number 5026808612. The drug was distributed to wholesalers across the United States between March 18 and March 21.

Consumer Advice

If you have acquired Atovaquone Oral Suspension from the recalled lot, it is imperative to discontinue use immediately. The medication should be either safely discarded or returned to the point of purchase for a refund. Furthermore, individuals who experience any adverse reactions to the medicine are advised to seek medical assistance promptly. They can also report any incidents to the FDA’s MedWatch program through their website or via phone at 800-332-1088.