AvKARE Recalls Atovaquone Oral Suspension
Potential Bacillus cereus contamination discovered during product testingAvKARE Recalls Atovaquone Oral Suspension
AvKARE, LLC has issued a voluntary recall of lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL due to potential Bacillus cereus contamination found during stability testing at a third-party lab.
The affected product, distributed nationwide to wholesalers between March 18, 2024, and March 21, 2024, is identifiable by lot# AW0221A and an expiration date of August 2025. The product is packaged in a carton with NDC # 50268-086-12 and UPC # 5026808612.
Atovaquone Oral Suspension is commonly used for the prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children who cannot tolerate other medications.
While there have been no reports of adverse events related to this recall, the risk of microbial contamination poses a serious threat, especially to immunocompromised individuals. In this population, contamination could lead to life-threatening infections such as endocarditis and necrotizing soft tissue infections.
Actions for Wholesalers and Consumers:
Wholesalers: Wholesalers who have the affected product in their inventory are advised to cease dispensing and return it to AvKARE, LLC.
Consumers: Consumers in possession of the recalled product should discontinue its use immediately. They can return the product to the place of purchase or dispose of it safely. Questions regarding the recall can be directed to AvKARE by phone at 1-855-361-3993 or via email at drugsafety@avkare.com.
Reporting Adverse Events:
Consumers and healthcare professionals are encouraged to report any adverse reactions or quality issues related to the use of this product to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online, by regular mail, or by fax using the contact information provided on the FDA’s website.
Conclusion:
This recall is being conducted with the cooperation of the U.S. Food and Drug Administration to ensure consumer safety. It is essential for wholesalers and consumers to take prompt action in response to this recall notice to minimize potential health risks. Stay informed and prioritize your health and safety.