Camber Pharmaceuticals issued a voluntary recall of one lot of atovaquone oral suspension used to treat a form of pneumonia. The recall is due to the potential of microbial contamination of Bacillus cereus.
In a filing posted on the FDA’s website, the company said the recall covers lot #E220182 of atovaquone, USP 750mg/5mL, at the consumer level. The drugs were packaged in 210 milliliter HDPE bottles with an expiration date of December 2023. The recalled lot was distributed to wholesalers, distributors, retail pharmacies and mail-order pharmacies nationwide.
The company said that, to date, it has not received any reports of adverse effects related to the recall.
Atovaquone is typically used to prevent and treat pneumocystis jiroveci pneumonia in adults and children 13 years and older who cannot tolerate other medicines such as trimethoprim-sulfamethoxazole.
Those most at risk for such a microbial contamination are immunocompromised patients. The contamination of B. cereus can cause life threatening infections such as endocarditis and necrotizing soft tissue infections.
New Jersey-based Camber was in the news last October after it joined the ranks of other drugmakers in reporting Adderall supply problems. That drug is used to treat attention-deficit/hyperactivity disorder.