Drug Safety Alerts

Atovaquone Oral Suspension, 750 mg/5 mL Consumer-Level Recall

8/6/2021

On August 6, 2021, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of Atovaquone Oral Suspension, 750 mg/5 mL, NDC #10702-0223-21. This recall was issued because of customer complaints of unusual grittiness in the product, which KVK Tech, Inc. (the manufacturer) has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment.

This recall affects lot numbers 16653A exp. 12/2022 and 16654A exp. 12/2022. No other lots are affected by this recall.

This could be a health hazard or safety risk to patients using product affected by this recall.

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. KVK Tech reports that to date it 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 teenagers and adults with human immunodeficiency virus (HIV) and is also used to prevent immunocompromised patients from contracting this type of pneumonia.

The product is packaged in 8 oz bottles (bottle of 210 mL with child-resistant cap) packaged in a carton, NDC #10702-0223-21, the affected lots are labeled 16653A and 16654A, with both lots having expiration dates of December 2022.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Atovaquone Oral Suspension, 750 mg/5 mL to contact their prescriber.

For more information, call KVK Tech at 215-579-1842, ext. 6002, Monday – Friday, 8:00 AM – 4:30 PM (EST) or email them at recall@kvktech.com. You may also call the U.S. Food and Drug Administration toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at https://www.fda.gov.