Atovaquone oral suspension, USP 750mg/5mL voluntarily recalled for potential Bacillus cereus contamination

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Camber Pharmaceuticals, Inc. has voluntarily recalled Atovaquone oral suspension, USP 750mg/5mL at the user and consumer levels, due to potential Bacillus cereus contamination in the product, according to a press release from the FDA announcing the recall.

Atovaquone oral suspension, USP is indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children aged 13 years and older, who cannot tolerate other medicines.

In the immunocompromised population—the most at risk population—there is a reasonable probability that microbial contamination of Atovaquone oral suspension can result in disseminated, life threatening infections like endocarditis and necrotizing soft tissue infections, according to Camber. As of March 13, 2023, Camber has not received reports of adverse events related to the recall.

The product, distributed nationwide to wholesalers, distributors, retail pharmacies, and mail order pharmacies, is packaged in a 210mL high-density polyethylene (HDPE) bottle in a mono carton. The NDC number associated with the product is 31722-629-21 and the UPC number is 331722629218. The affected lot number is E220182 and has an expiration date of December 2023.

Those using Atovaquone oral suspension, USP 750mg/5mL, including consumers, distributors, and retailers, should stop using and return to place of purchase, discard, or contact their doctor according to the manufacturer.

According to the press release, Camber Pharmaceuticals, Inc. is notifying customers and distributors through mailing and email communications by reverse logistics company, Inmar, to arrange returns for all recalled Atovaquone oral suspension. 

Per Camber, those with questions regarding the recall can contact Inmar by phone at 1-877-597-0878 or email rxrecalls@inmar.com. Consumers that experience any problems that could be related to taking Atovaquone oral suspension, USP 750mg/5mL should contact their physician or health care provider.

Reference

Camber pharmaceuticals, inc. issues voluntary nationwide recall of Atovaquone oral suspension, USP750mg/5ml due to potential bacillus cereus contamination in the product. US Food and Drug Administration. Published March 31, 2023. Accessed April 3, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp