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KVK Tech, Inc., is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mLto the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment.
Exposure of Atovaquone Oral Suspension to extremely low temperatures, during shipment (the product is required to be protected from freezing temperatures), may result in changes to the effectiveness, appearance, taste and thickness of the liquid. 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.
Atovaquone is a prescription drug labeled to treat Pneumocystis jiroveci [Pneumocystis carinii] pneumonia, a type of pneumonia most likely to affect people with human immunodeficiency virus (HIV) in teenagers and adults and is also used to prevent immunocompromised patients from contracting this type of pneumonia.
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