April 3, 2023- Chamber Pharmaceuticals has recalled lot # E220182 of their Atovaquone Oral Suspension voluntarily due to the potential Bacillus cereus contamination within the product.
FDA Risk Statement:
Currently those at most risk are those who are immunocompromised, 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. Currently, Chamber has not received any reports regarding the adverse events related to the recall.
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.
The product 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.
Consumers with questions regarding this recall can contact Inmar by phone at 1-877-597-0878 or email [email protected], Monday – Friday, 9am – 5pm Eastern Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178