Class I Recall for Pneumonia Medication

Potential microbial contamination has prompted a Class I recall of 1568 bottles of atovaquone oral suspension distributed throughout the United States. According to the May 17, 2023, US Food and Drug Administration (FDA) Enforcement Report, Bacillus cereus was found in the medication during testing of the repackaged drug.

“In the population most at risk, [the] 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,” recalling firm Camber Pharmaceuticals Inc stated in a March 13, 2023, announcement. “To date, Camber has not received any reports of adverse events related to this recall.”

The recall affects atovaquone oral suspension, 750 mg/5 mL, packaged in 210-mL bottles (NDC 31722-629-21, UPC 331722629218), from lot E220182 (Exp 12/23). The product was manufactured by Hetero Labs Limited, Jeedimetla, Hyderabad, India, for Camber Pharmaceuticals, Piscataway, New Jersey, and was distributed to wholesalers, distributors, retail pharmacies, and mail-order pharmacies nationwide. 

Camber Pharmaceuticals voluntarily initiated the recall March 13, 2023. On May 8, 2023, the FDA designated the recall Class I. The classification is the FDA’s most serious drug recall designation and warns use of the affected product could cause serious adverse health consequences or death.

Atovaquone oral suspension is a prescription medication indicated for the prevention and treatment of Pneumocystis jiroveci pneumonia in adults and children 13 years of age and older who cannot tolerate trimethoprim-sulfamethoxazole.