FDA MedWatch - Atovaquone Oral Suspension - USP, 750 mg/ 5mL by KVK Tech:

Recall - Due to Temperature Abuse

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Atovaquone Oral Suspension - USP, 750 mg/ 5mL by KVK Tech: Recall - Due to Temperature Abuse AUDIENCE: Patient, Pharmacy, Infectious Disease  ISSUE: KVK Tech, Inc., is recalling two lots of Atovaquone Oral Suspension - USP, 750 mg/ 5 mL based on customer complaints of an unusual grittiness in the product. The affected lots are labeled 16653A and 16654A, with both lots having expiration dates of December 2022. 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. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: 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. RECOMMENDATIONS:  Patients or caregivers who have bottles of atovaquone affected by this recall should stop using and return the product to KVK Tech. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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