A drug made by a Florida company has been recalled for a possibly lethal contamination
A New Jersey company recalled one batch of a drug made in Florida and sold nationwide after finding a potentially deadly bacterial contamination.
The FDA-posted recall notice from Princeton, New Jersey’s Bionpharma said batch No. 2310083 of Atovaquone Oral Suspension, 750 mg, NDC No. 69452-252-87, was “found to be contaminated with Cohnella bacteria.”
As for what that can mean, the risk statement says for people with compromised immune systems, the microbial contamination “can result in disseminated, life threatening infections such as inflammation of the heart and permanent damage to soft tissue.”
Atovaquone is an antimicrobial medication designed to prevent pneumonia in adults and teenagers. CoreRx, based in the Clearwater suburb of Largo, made the recalled batch on Oct. 26, 2023, with an expiration date of September 2025.
In addition to the recall, Bionpharma said, the company is “implementing enhanced quality control measures with our manufacturer, CoreRx, Inc. to prevent recurrence.”
Distributors or pharmacies with the recalled lot should separate it from active inventory. People with the recalled Atovaquone should take it back to the pharmacy where it was bought. Any questions should be directed to Biopharma at 888-235-2466, Monday through Friday, 9 a.m. to 5 p.m., Eastern time, or by emailing drugsafety@bionpharma.com.
Take any medical problems to a medical professional. Then, notify the FDA via the MedWatch program, either by filling out the form online or calling 800-332-1088 to get a form, then submitting it by mailing the form to the address on the form or faxing it to 800-FDA-0178.