A recall of 2 lots of Atovaquone Oral Suspension 750mg/mL has been initiated by KVK Tech, Inc.

Atovaquone, a quinone antimicrobial drug, is indicated for the acute treatment of mild to moderate Pneumocystis jirovecii pneumonia (PCP), and to prevent PCP, in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole. 

The recall was initiated because the product had prolonged exposure to extremely cold weather during shipment. Exposure to extremely low temperatures can affect the appearance, taste and thickness of the liquid, as well as change the effectiveness of the medication. The product is required to be protected from freezing temperatures.

The affected lots are labeled 16653A and 16654A, with an expiration date of December 2022. The product is packaged in 8oz bottles, packaged in a carton with NDC# 10702-223-21.


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Recalled label. Credit: KVK Tech.

Individuals with questions related to the recall can contact KVK Tech at 215-579-1842, extension: 6002 or email [email protected]. Adverse events or quality issues should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program. To date, the Company is unaware of any adverse events associated with use of the affected product.

Reference

KVK Tech Inc., issues voluntary nationwide recall of Atovaquone Oral Suspension, USP 750mg/5mL due to temperature abuse. News release. August 6, 2021. https://www.prnewswire.com/news-releases/kvk-tech-inc-issues-voluntary-nationwide-recall-of-atovaquone-oral-suspension-usp-750-mg5ml-due-to-temperature-abuse-301350432.html.