AvKARE, LLC., a pharmaceutical company, has issued a voluntary recall for a specific lot of its Atovaquone Oral Suspension, USP 750 mg/5 mL. The reason behind this recall is the possible contamination of the product with Bacillus cereus, a bacterium that can pose serious health risks.
Background
The recall was initiated because the potential for Bacillus cereus contamination was found through 3rd party testing. According to AvKARE, “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.”
Distribution
The recalled product was distributed nationwide to AvKARE’s wholesales between March 18, 2024 and March 21, 2024.
Product Details
- Product Name: Atovaquone Oral Suspension, USP 750 mg/5 mL
- Packaging: Carton
- Lot Number: AW0221A
- Expiration Date: August 2025
- National Drug Code (NDC): 50268-086-12
- UPC: 5026808612
What Consumers Should Do
- Check their home for the affected product
- If the product is found, stop using, and return to the point of purchase or discard immediately
- For additional questions or concerns, contact AvKARE at 855-361-3993 between 9am and 5pm Eastern Time, Monday through Friday or email [email protected]
Wholesalers are requested to inspect their inventory and cease dispensing the impacted lot. Any affected product should be returned to AvKARE.
Potential Health Risks
Fortunately, no illness or adverse events have been reported to date but consumers should check with their healthcare providers if they have any concerns about potential infection from the recalled product.
Food Poisoning News recently reported on the risk of Bacillus cereus. A spore-forming pathogen, Bacillus cereus can produce toxins capable of causing food poisoning in humans. Common food poisoning symptoms include abdominal cramps, diarrhea, nausea, and vomiting. In the case of Atovaquone Oral Suspension, AvKARE notes that especially in immunocompromised individuals, contamination with Bacillus cereus could lead to severe infections such as endocarditis, an inflammation of the heart lining, and necrotizing soft tissue infections.
According to a national food safety lawyer, “Bacillus cereus can be a deadly pathogen that can cause serious issues for consumers. It’s critical for those in possession of the affected product to throw it away and also see their doctor immediately if they’ve consumed the product and are showing symptoms of infection.”
