A single lot (#AW0221A) of Atovaquone Oral Suspension, USP 750mg/5ML, under the AVpak brand, has been recalled by AvKARE, LLC because the product may be contaminated with Bacillus cereus, reports the FDA.
The voluntary, consumer-level recall was initiated by the company on April 1, 2024, after a third-party lab conducted stability testing that found traces of the organism. By then, Atovaquone Oral Suspension, USP had already been distributed and made available for purchase between March 18, 2024 and March 21, 2024 by wholesalers across the country.
Indicated for the prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children older than 13, it is often an option for those who have no tolerance for other medicines that include trimethoprimsulfamethoxazole.
According to officials, the potential contamination poses a particular risk to those who are immunocompromised, as there is a higher likelihood that a microbial contamination in the product could lead to more serious conditions such as disseminated infections known to be life-threatening, as in the case of “endocarditis and necrotizing soft tissue infections.”
As seen in the product photo attached in the FDA announcement, Atovaquone Oral Suspension comes packaged in a carton bearing NDC #50268-086-12, UPC (Universal Product Code) #5026808612, lot #AW0221A, and a 08/2025 expiration date.
AvKARE, LLC has since alerted distributors and wholesale customers via regular mail and email about the recall, and is working to establish a return program for all recalled products.
Although AvKARE has not been alerted to any reports of illness or other adverse events related to the issue, anyone in possession of the product is ask to cease all use. The item should either be returned to the point of purchase or disposed of. AvKARE can be reached for more questions about the recall by calling 1-855-361-3993, or via email at drugsafety@avkare.com. Representatives can be reached Monday through Friday, from 9:00 a.m. to 5:00 p.m. Eastern Time.
Anyone experiencing health problems believed to be connected to use of the drug product is advised to consult their physician or healthcare provider.
As the FDA continues to monitor the issue, those who encounter adverse reactions or quality issues are urged to report to the agency’s MedWatch program.
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