Camber Recalls Atovaquone Oral Suspension USP for Potential Contamination
Camber Pharmaceuticals Inc. recently issued a voluntary nationwide recall of Atovaquone Oral Suspension USP due to potential contamination. The recall was announced by the U.S. Food and Drug Administration (FDA) on March 25, 2023. The affected product was distributed to wholesalers, distributors, and retailers across the United States.
What is Atovaquone
Atovaquone is an oral suspension used to treat and prevent certain types of pneumonia, as well as to prevent malaria. The recall was initiated after routine testing by the company identified the presence of a foreign substance in some batches of the product. Although no adverse events related to the contamination have been reported to date, the company is taking this precautionary measure to ensure the safety of patients.
Class II recall
The FDA has classified this recall as a Class II recall, which means that the use of, or exposure to, the recalled product may cause temporary or medically reversible health consequences. However, the probability of serious adverse health consequences is remote.
Higher-risk population
This product recall is especially important for immunocompromised patients, where a microbial contamination of the product can result in potentially, life-threatening infections, to include endocarditis and necrotizing soft tissue infections.
Affected products
The affected product is packaged in 750 mg/5 mL bottles with the NDC number 31722-062-01. The affected lot numbers are 71174, 71175, 71176, and 71177, with expiration dates ranging from June 2023 to August 2023. Consumers who have been prescribed Atovaquone Oral Suspension USP should check the lot number and expiration date of their medication and return any affected product to their pharmacy.
Actions to take if you have the product
Distributors and retailers who have the product should contact Camber for more information. Consumers who have the recalled product should discontinue its use immediately and discard the product or return it to the pharmacy. Users of the medication who have questions should contact their physician and report any adverse health affects related to product use to FDA’s MedWatch reporting system.
Company actions
The company has notified its distributors and customers via email and is arranging for the return of all recalled products. Camber Pharmaceuticals Inc. is also advising healthcare professionals and consumers to report any adverse reactions or quality problems to the FDA’s MedWatch program.
Importance of testing and quality control
This recall serves as a reminder of the importance of routine testing and quality control measures in the pharmaceutical industry. The FDA works closely with companies to ensure that their products meet established safety standards and regulatory requirements. Patients and healthcare professionals can also help to ensure the safety of medications by reporting any adverse events or quality concerns to the FDA via its MedWatch program.
Industry vigilance
In conclusion, the voluntary nationwide recall of Atovaquone Oral Suspension USP by Camber Pharmaceuticals Inc. underscores the importance of vigilance in the pharmaceutical industry. Patients who have been prescribed this medication should check the lot number and expiration date of their medication and return any affected product to their pharmacy. Healthcare professionals and consumers should report any adverse reactions or quality problems to the FDA’s MedWatch program. By working together, we can help to ensure the safety and efficacy of medications for all patients.
More details
Read the FDA announcement here.