Atovaquone Oral Suspension USP, 750 mg/5 mL by Camber Pharmaceuticals: Recall - Due to Potential Bacillus cereus Contamination in the Product

 

To: All healthcare facilities in Colorado From: Colorado Department of Public Health and Environment   ISSUE: Camber Pharmaceuticals is recalling lot # E220182 of Atovaquone Oral Suspension USP, 750 mg/5 mL due to the potential Bacillus cereus contamination in the product.   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, Camber has not received any reports of adverse events related to this recall.   For more information about this recall, click here.   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/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc. Patients with questions regarding this recall can contact the company. Camber Pharmaceuticals is notifying its distributors and customers and is arranging for returns of all recalled Atovaquone Oral Suspension, USP. 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.