Atovaquone Oral Suspension Recalled

KVK Tech is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL because of customer complaints of unusual grittiness in the product.

According to an FDA August 6, 2021 announcement, KVK Tech is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL because of customer complaints of unusual grittiness in the product. The company has determined that the grittiness was most likely caused by extremely cold weather during shipment.

Because the product must be protected from freezing temperatures, exposure to extremely low temperatures during shipment may cause product changes, according to the company, which can make it less effective.

The recalled lots are labeled 16653A and 16654A and have expiration dates of December 2022. The company stated in a press announcement that it is unaware of any adverse events associated with the recall. Adverse events may be reported to FDA through the agency’s MedWatch program.

Source: FDA