Safety Report: Camber Atovaquone Oral Suspension, USP - recalled due to Bacillus cereus, USA

United States

Piscataway, NJ, Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product. This product was distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies. To date, Camber has not received any reports of adverse events related to this recall.

Atovaquone Oral Suspension, USP 750mg/5mL is packaged in 210mL HDPE bottle in a mono carton. The identified NDC # associated with the product is 31722-629-21, UPC # 331722629218, and the affected lot# is E220182 with an expiration date of 12/2023.

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.

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.

Camber Pharmaceuticals, Inc. is notifying its distributors and customers by their Reverse Logistics Company, Inmar, by mailings and emails communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP.

Consumers/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Camber Pharmaceuticals, Inc.
Brand name: Camber
Product recalled: Device & Drug Safety/Microbial Contamination/Bacillus cereus
Reason of the recall: Potential Bacillus cereus Contamination
FDA Recall date: March 31, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/camber-pharmaceuticals-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp