Life-Saving Medication Manufactured in FL Recalled Over Bacterial Contamination

Product photoPhoto byFDA press release

Bionpharma Inc. has issued a voluntary nationwide recall of a single batch (2310083) of a pneumonia treatment, Atovaquone Oral Suspension, 750 mg/mL, due to bacterial contamination. The affected product was manufactured by CoreRx, Inc. in Clearwater, Florida, and distributed across the United States between December 2023 and June 2024.

The recall follows the discovery of Cohnella bacteria in the affected batch, a contaminant that poses serious risks, particularly to immunocompromised individuals. Exposure to this bacteria can lead to life-threatening infections, including heart inflammation and permanent soft tissue damage. No adverse events have been reported as of the recall announcement.

Details of the Affected Product:

• Product Name: Atovaquone Oral Suspension, 750 mg/mL
• NDC: 69452-252-87
• Batch Number: 2310083
• Expiration Date: September 2025
• Production Date: October 26, 2023
• Release Date: December 05, 2023

What Consumers Should Do: Consumers who have purchased the affected batch are urged to stop using the product immediately and return it to the place of purchase. For questions, Bionpharma’s customer support can be reached at 888-235-2466 (Mon-Fri, 9 AM to 5 PM EST) or via email at drugsafety@bionpharma.com.

Healthcare professionals and consumers are encouraged to report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting program online or by fax at 1-800-FDA-0178.

This recall is being conducted with the oversight of the U.S. Food and Drug Administration (FDA).