FDA MedWatch – Atovaquone Oral Suspension USP, 750 mg/5 mL by AvKARE

TOPIC: Atovaquone Oral Suspension USP, 750 mg/5 mL by AvKARE: Recall – Due to Potential Bacillus cereus Contamination

AUDIENCE: Patient, Health Professional, Pharmacy, Pulmonology

ISSUE: AvKARE is recalling lot # AW0221A of Atovaquone Oral Suspension USP, 750mg/ 5mL due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab.

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. 

To date, AvKARE has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button “Read Recall“ below.

BACKGROUND: 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.

RECOMMENDATIONS: 

• Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

• Patients that have product which is being recalled should stop using the product and return it to place of purchase or discard.

• Patients with questions regarding this recall can contact AvKARE by phone at 1-855-361-3993 or email drugsafety@avkare.com.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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