Atovaquone Oral Suspension Has Been Recalled; And Here Is Why -DETAILS

Atovaquone Oral Suspension Has Been Recalled; And Here Is Why -DETAILS

Atovaquone Oral Suspension, USP 750mg/5mL, lot # E220182, manufactured by Camber Pharmaceuticals, Inc., is voluntarily being recalled owing to a possible Bacillus cereus infection.

Risk Statement: There is a chance that microbial contamination of atovaquone oral suspension can cause widespread, potentially fatal infections such endocarditis and necrotizing soft tissue infections in the immunocompromised population, which is the population most at risk. Camber has not yet heard of any reports of unfavorable incidents connected to this recall.

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 is recommended for PCP prophylaxis and treatment.

To wholesalers, distributors, retail pharmacies, and mail-order pharmacies, atovaquone oral suspension, USP, was delivered nationwide.

The item is presented in a mono carton with a 210mL HDPE bottle. The problematic lot number is E220182, with an expiration date of 12/2023, and the discovered NDC number for the product is 31722-629-21.

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 is recommended for PCP prophylaxis and treatment.

To wholesalers, distributors, retail pharmacies, and mail-order pharmacies, atovaquone oral suspension, USP, was delivered nationwide.

The item is presented in a mono carton with a 210mL HDPE bottle. The problematic lot number is E220182, with an expiration date of 12/2023, and the discovered NDC number for the product is 31722-629-21.

Camber Pharmaceuticals, Inc. is arranging for the return of all recalled Atovaquone Oral Suspension, USP while also contacting its distributors and customers via our Reverse Logistics Company, Inmar, via mailings and emails.

Customers, distributors, and retailers that have recalled goods should cease using them, return them to the store where they were bought them, throw them away, call their doctor, etc.

Customers can reach Inmar via phone at 1-877-597-0878 or by email at rxrecalls@inmar.com, Monday through Friday, 9am to 5pm Eastern Time, with any concerns about this recall. If users have any issues that might be related to consuming or using this drug product, they should get in touch with their doctor or healthcare practitioner.

Online, by regular mail, or by fax, users of this product may report any adverse reactions or quality issues to the FDA’s MedWatch Adverse Event Reporting program.

Complete the online form and submit it at www.fda.gov/medwatch/report.htm.
Regular Mail or Fax: To request a reporting form, go to www.fda.gov/medwatch/getforms.htm or dial 1-800-332-1088. Download the form, fill it out, and mail it to the address on the pre-addressed envelope, or fax it to 1-800-FDA-0178.

The U.S. Food and Drug Administration is aware of this recall and is cooperating.