USDA And Fedwatch Recall Alerts

Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination

FOR IMMEDIATE RELEASE – September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria.

Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as inflammation of the heart and permanent damage to soft tissue. To date, Bionpharma has not received any reports of adverse events related to this recall.

We take these findings seriously and are taking immediate action to address the situation. We have initiated a recall of the (1) affected batch listed below and are implementing enhanced quality control measures with our manufacturer, CoreRx, Inc. to prevent recurrence. Our priority remains the safety and well-being of our consumers, and we are committed to transparency throughout this process.

This product is a quinone antimicrobial drug indicated for prevention of pneumocycstis jirovecii pneumonia (formerly known as PCP for pneumocystis carinii pneumonia) in adults and adolescents aged 13 and older. The affected batch of product was manufactured at CoreRx, Inc. and shipped nationwide to our customers between December 21, 2023 and June 20, 2024 and distributed through wholesalers and retailers.