August 6, 2021

KVK Tech, Inc., has voluntarily recalled two lots of Atovaquone Oral Suspension, USP 750 mg/5mL, following customer complaints that the product was unusually gritty. KVK determined the grittiness was likely due to prolonged exposure to extremely cold weather during shipment.

Atovaquone oral suspension should not be exposed to freezing temperatures. These temperatures can alter the effectiveness, appearance, taste, and thickness of the solution. Although KVK had received no reports of adverse events related to the issue as of the date of the recall, there is a chance that use of less effective atovaquone could lead to serious, life-threatening infections in immunocompromised individuals. The product is U.S. FDA approved to treat and prevent Pneumocystis jiroveci pneumonia in teenagers and adults. The disease is caused by a yeast-like fungus and most likely to affect individuals diagnosed with human immunodeficiency virus (HIV) infection.

The affected product is labeled with lot number 16653A or 16654A and expires in December 2022. It was shipped to a single distributor. KVK has notified the distributor and is working with them to make certain remaining inventory of the recalled lots is returned to KVK.

Per the recall notice, patients or caregivers who have the recalled atovaquone in their possession should stop using it and return it to KVK Tech at 110 Terry Drive, Newtown, PA 18940. KVK will arrange to reimburse customers for product purchase costs. Consumer questions regarding the recall can be directed to KVK at 215-579-1842, ext. 6002, or recall@kvktech.com. Any problems that may have been related to use of the recalled product should be reported to the patient’s healthcare provider. Adverse events can also be reported to the FDA’s MedWatch program.

A copy of the recall notice is available on the FDA’s website.

There is no impact to members through Benecard Central Fill.

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