Pneumonia medication recalled nationwide for bacteria contamination

(WHTM) — A medication that is used to prevent Pneumonia has been recalled nationwide due to bacterial contamination.

According to the Food & Drug Administration , the New Jersey-based Bionpharma Inc. has voluntarily recalled a batch of its Atovaquone Oral Suspension, 750mg, an antimicrobial drug used to prevent pneumonia.

The product, manufactured by CoreRx, Inc. in Clearwater, Florida, was recalled because it was found to be contaminated with Cohnella bacteria.

The FDA says that in the population most at risk (immunocompromised individuals), there is a probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life-threatening infections, including inflammation of the heart and permanent damage to soft tissue.

To date, Biopharma 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. “We have initiated a recall of the (1) affected batch listed below and are implementing enhanced quality control measures with our manufacturer, CoreRx, Inc. to prevent recurrence. Our priority remains the safety and well-being of our consumers, and we are committed to transparency throughout this process.”

The affected batch of medication was shipped nationwide to customers between December 21, 2023, and June 20, 2024, and was distributed through wholesalers and retailers.

This recall includes the following product and batch number:

The lot number can be found on the side panel of the bottle or on the bottom flap of the carton.

The Company is currently notifying its distributors and customers by email and is arranging for return/replacement of the recalled batch of the product. Consumers who 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 send an email to drugsafety@bionpharma.com .

If you encounter adverse reactions or quality problems with the use of this product, you can report it to the FDA’s MedWatch Adverse Event Reporting Program either online or by regular mail or fax (1-800-FDA-0178) .

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