Class I Recall for Antifungal Medication

A voluntary recall initiated by KVK Tech Inc for two lots of atovaquone oral suspension has been designated Class I by the US Food and Drug Administration (FDA), according to the September 1, 2021, FDA Enforcement Report. The classification signals that use of the affected product could cause serious adverse health consequences or death. 

The recall was initiated by KVK Tech after customers reported unusual grittiness in the product. According to the company, the issue was likely caused by the medication’s exposure to extremely cold weather during shipment. 

“Exposure of atovaquone oral suspension to extremely low temperatures … may result in changes to the effectiveness, appearance, taste, and thickness of the liquid,” the company stated in an August 6, 2021, press release. “Severely immunocompromised patients who receive less effective atovaquone oral suspension may experience inadequate treatment of serious and life-threatening infections. To date, KVK Tech is not aware of any adverse events associated with this problem.” 

The recall affects 1692 bottles of atovaquone oral suspension, 750 mg/5 mL, 210-mL bottles (NDC 10702-223-21), from lots 16653A (Exp. 12/22) and 16654A (Exp. 12/22). The product was manufactured by KVK Tech, Newtown, PA, and sent to one distributor, who may have further distributed the medication throughout the United States. 

KVK Tech voluntarily initiated the recall July 2, 2021. 

Atovaquone is a prescription medication used to treat or prevent Pneumocystis jiroveci (Pneumocystis carinii) pneumonia in patients who are immunocompromised.