Bionpharma Inc. has issued a recall foir a single batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, Fla., and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria.
In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as inflammation of the heart and permanent damage to soft tissue. To date, Bionpharma has not received any reports of adverse events related to this recall.
“We take these findings seriously and are taking immediate action to address the situation,” the company said in a statement. “We have initiated a recall of the affected batch and are implementing enhanced quality control measures with our manufacturer, CoreRx, Inc. to prevent a recurrence. Our priority remains the safety and well-being of our consumers, and we are committed to transparency throughout this process.”
This product is a quinone antimicrobial drug indicated for prevention of pneumocycstis jirovecii pneumonia (formerly known as PCP for pneumocystis carinii pneumonia) in adults and adolescents aged 13 and older. The affected batch of product was manufactured at CoreRx, Inc. and shipped nationwide to our customers between December 21, 2023 and June 20, 2024 and distributed through wholesalers and retailers.
The recall includes the following product and batch number:
Production Date | Release Date | Product Name | NDC | Lot No. | Expiration Date |
October 26, 2023 | December 05, 2023 | Atovaquone Oral Suspension | 69452-252-87 | 2310083 | September 2025 |
What to do
The company said it is notifying its distributors and customers by email and is arranging for return/replacement of the recalled batch of the product. Distributors/retailers that have affected lot of the drug product which is being recalled should immediately cease distribution and remove it from active inventory. Consumers that have the affected lot of the product should stop using the product and return to the place of purchase.
Consumers with questions regarding this recall can contact Bionpharma by phone at (888) 235-2466 (Mon-Fri 9AM-5PM EST) or via email to drugsafety@bionpharma.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the affected lot of the drug product.