According to the FDA, Bionpharma Inc. is recalling one lot of Atovaquone Oral Suspension, 750 mg per mL, after discovering Cohnella bacteria in the product. The Drug Safety Department of Bionpharma Inc. announced the recall on September 17, 2024. It applies to bottles produced on October 26, 2023, and released on December 05, 2023, with an expiration date of September 2025.
The lot number for the contaminated batch of Atovaquone Oral Suspension, 750 mg per mL, is 2310083, and the National Drug Code (NDC) is 69452-252-87. CoreRx, manufactured the product, and shipped it for nationwide distribution between December 21, 2023 and June 20, 2024. The medication is sold in a white plastic bottle that is packaged inside of a white paper box. Customers can find the NDC at the top of the bottle on its front side. The lot number and expiration date are printed on the side label of the bottle and can also be found printed on the box.
Atovaquone Oral Suspension is prescribed to individuals 13 and older for the prevention and treatment of pneumocycstis jirovecii pneumonia. According to the CDC, this is a rare type of pneumonia caused by a fungal infection of the lungs. People with significantly compromised immune systems or who take corticosteroids are most at risk for getting pneumocycstis jirovecii pneumonia.
The company has not yet received any reports of illness or injury linked to this batch of Atovaquone Oral Suspension, but they urge customers not to use the product. They say that Chonella bacteria can cause serious, life-threatening infections in patients with compromised immune systems. Such infections could lead to “inflammation of the heart and permanent damage to soft tissue.”
Bionpharma Inc. asks that distributors and retailers cease selling all bottles of Atovaquone Oral Suspension from lot 2310083. The company plans to contact customers directly to arrange replacement from an unaffected lot. Customers who do not receive the email can return the medication to the point of purchase.
Patients who experience unusual symptoms after taking the recalled product should contact their healthcare provider immediately.
Anyone with questions about the recall can contact Bionpharma Inc. at (888) 235-2466 (Mon-Fri 9 am-5 pm, EST) or via email at drugsafety@bionpharma.com.
Patients and health care providers can report any new adverse health events related to taking Atovaquone Oral Suspension, 750 mg per mL, through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a family member have suffered an adverse reaction after taking a contaminated medication, the attorneys at TruLaw would like to learn about your case. Such exposures can cause serious health problems, and you deserve fair compensation for your pain and suffering. Our team will help you fight for a just legal outcome. Reach out to our firm today or start by taking our free Instant Case Evaluation ℠.