Voluntary nationwide recall: Atovaquone (Bionpharma – September)

Bionpharma Inc. is recalling one lot, lot 2310083, of Atovaquone Oral Suspension, 750 mg/mL. Atovaquone is used to prevent a fungal infection called pneumocystis jirovecii pneumonia in adults and adolescents age 13 and older.

This drug is being recalled because Cohnella bacteria was found in the product. Using this contaminated drug can cause life-threatening swelling of the heart and permanent damage to the body’s soft tissue.

To see if your medication was recalled, contact your doctor or pharmacy where you received it or visit the FDA website below. If you have an affected lot of Atovaquone, you should stop using the product and return it to the place of purchase.

As of Sept. 17, there had been no reports of adverse events related to this recall.

To learn more about this recall, you can take one or more of the steps below.

• Talk to your doctor or pharmacist.
• Call Bionpharma at 1-888-235-2466. TTY users should call 711. Help is available Monday through Friday from 9 a.m. to 5 p.m. EST.
• Visit the FDA website.