The therapy for HIV-related pneumonia was exposed to cold weather during shipment.
KVK Tech is voluntarily recalling two lots of atovaquone oral suspension, USP 750 mg/5ml. The recall includes any medication that patients may received. The recall is based on customer complaints of unusual grittiness in the product. This most probably was caused by prolonged exposure to cold weather when it had been shipped, company officials said.
Exposure to extremely low temperatures may result in changes to the effectiveness, appearance, taste and thickness of the liquid. Severely immunocompromised patients who receive less effective atovaquone may experience inadequate treatment effect. To date, KVK Tech is not aware of any adverse events associated with this problem.
Atovaquone treats Pneumocystis carinii pneumonia, a type of pneumonia most likely to affect people with HIV. It is also used to prevent immunocompromised patients from contracting this type of pneumonia.
The product is packaged in eight-ounce bottles (bottle of 210 mL with child-resistant cap) with NDC 10702-223-21. The affected lots are labeled 16653A and 16654A. Both lots have expiration dates of December 2022.