Safety Report: AvKARE, LLC Atovaquone Oral Suspension - recalled due to potential Bacillus cereus contamination, USA

United States

AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab. Atovaquone Oral Suspension, USP was distributed between 03/18/2024 through 03/21/2024 Nationwide to Wholesalers. To date, AvKARE has not received any reports of adverse events related to this recall.

Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections.

Atovaquone Oral Suspension, USP is indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole.

The product is packaged in a carton. The identified NDC # associated with the product is 50268-086-12, UPC # 5026808612 and the affected lot# is AW0221A with an expiration date of 08/2025.

AvKARE, LLC is notifying its distributors and wholesale customers by mailings and email communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP. Wholesalers who have Atovaquone Oral Suspension, USP 750mg/5mL, which are being recalled, should examine their inventory and cease dispensing, return any of the impacted lots to AvKARE, LLC. Consumers that have product which is being recalled should stop using the product and return it to place of purchase.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.  

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: AvKARE, LLC
Brand name: AVpak
Product recalled: Atovaquone Oral Suspension, USP 750mg/5mL
Reason of the recall: Potential Bacillus cereus contamination
FDA Recall date: April 01, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due