Why Atovaquone Oral Suspension Has Been Recalled; FDA Releases Verified Cause for Recall of Atovaquone Oral Suspension

Why Atovaquone Oral Suspension Has Been Recalled; FDA Releases Verified Cause for Recall of Atovaquone Oral Suspension

Atovaquone Oral Suspension has been recalled due to a potential Bacillus cereus infection.

According to report that captured Risk Statement reads that, in the immunocompromised population, which is the population most at risk, there is a possibility that microbial contamination of atovaquone oral solution can result in extensive, potentially fatal illnesses such endocarditis and necrotizing soft tissue infections. Camber has not yet been made aware of any complaints of situations that are adverse in relation to this recall.

Atovaquone Oral Suspension, USP is advised for PCP prophylaxis and therapy when other medications, such as trimethoprim-sulfamethoxazole, are not tolerated by adults or children 13 years of age and older, such as PCP patients.

Atovaquone oral suspension, USP, was sent out to wholesalers, distributors, retail pharmacies, and mail-order pharmacies countrywide.

A 210mL HDPE bottle and a mono carton containing the product are included. The product’s NDC number was found to be 31722-629-21, and the problematic lot number is E220182, with an expiration date of 12/2023.

Atovaquone Oral Suspension, USP is advised for PCP prophylaxis and therapy when other medications, such as trimethoprim-sulfamethoxazole, are not tolerated by adults or children 13 years of age and older, such as PCP patients.

Atovaquone oral suspension, USP, was sent out to wholesalers, distributors, retail pharmacies, and mail-order pharmacies countrywide.

A 210mL HDPE bottle and a mono carton containing the product are included. The product’s NDC number was found to be 31722-629-21, and the problematic lot number is E220182, with an expiration date of 12/2023.

In addition to arranging for the return of all recalled Atovaquone Oral Suspension, USP, Camber Pharmaceuticals, Inc. is mailing letters and sending emails to its distributors and clients on behalf of our Reverse Logistics Company, Inmar.

Consumers, distributors, and retailers who have purchased recalled products should stop using them, return them to the place of purchase, throw them away, and make a doctor’s appointment, among other actions.

If a customer has any questions about this recall, they can get in touch with Inmar via phone at 1-877-597-0878 or by email at rxrecalls@inmar.com, Monday through Friday, 9am to 5pm Eastern Time. Users should contact their physician or other healthcare professional if they have any problems that may be caused by using or using this medicinal product.

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