Atovaquone recall issued for oral suspension due to potential bacteria contamination

Atovaquone recall overview: 

• Who: AvKARE LLC issued a voluntary recall for one lot of Atovaquone Oral Suspension, USP 750mg/5mL to the consumer/user level. 
• Why: The recall was initiated over concerns the product was contaminated with Bacillus cereus bacteria.
• Where: The recalled product was distributed to wholesalers nationwide. 

AvKARE LLC issued a voluntary recall for one lot of its 750mg Atovaquone oral suspension to the consumer/user level over concerns it was contaminated with the bacteria Bacillus cereus. 

The potential bacteria contamination was found during stability testing of the Atovaquone oral suspension — which is used for the prevention and treatment of Pneumocystis jiroveci pneumonia in certain adults and children older than 13 — at a third-party lab, according to a recall published April 1 by the U.S. Food and Drug Administration. 

The recalled Atovaquone oral suspension was distributed to wholesalers nationwide between March 18 and 21, according to the recall. 

Consumers advised to stop using, return recalled atovaquone product

The recall advises consumers to stop using the recalled Atovaquone oral suspension and return it to its place of purchase or discard it. Consumers should report any problems they may have experienced in connection with having taken the drug product to their physician or healthcare provider. 

The recall also advises wholesalers to examine their inventory and stop dispensing any recalled Atovaquone oral suspension in their possession, and to return any impacted lots to AvKARE. 

Individuals with more questions about the recall can contact AvKARE directly by telephone at 1-855-361-3393 or through the company’s email. 

The recall comes just over a year after Camber Pharmaceuticals Inc. issued a recall for some of its Atovaquone oral suspension pneumonia medication in March 2023 over concerns it may have been contaminated with Bacillus cereus.

Are you affected by the recall? Let us know in the comments.

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