Lung Infection Medication Recalled Nationwide Over Possible Bacterial Contamination

A combination of photos show Atovaquone Oral Suspension, 750 mg/mL, for which a voluntary nationwide recall was issued by the company over potential bacterial contamination. Bionpharma Inc. via FDA

Drug manufacturer Bionpharma Inc. is voluntarily recalling one of its medications used to treat serious lung infections, over possible Cohnella bacteria contamination, according to the U.S. Food and Drug Administration (FDA).

The Princeton, New Jersey-headquartered company is recalling single batches of its 750 mg/mL Atovaquone Oral Suspension, a Sept. 18 FDA notice said.

The affected batches of the product were manufactured by CoreRx Inc. in Clearwater, Florida, before being distributed by Bionpharma Inc. nationwide to customers between Dec. 21, 2023 and June 20, 2024.

They were also distributed through wholesalers and retailers, the FDA said.

According to the notice, the affected product comes in a white plastic bottle and has a lot number of 2310083, which can be found on the side panel of the bottle or the bottom flap of the carton.

The item also has an expiry date of September 2025.

The agency said the product at the center of the recall is a quinone antimicrobial drug used to prevent and treat pneumocycstis jirovecii pneumonia (formerly known as pneumocystis carinii pneumonia, or PCP)—a rare but serious lung infection—in adults and adolescents aged 13 and older.

Pneumocycstis jirovecii pneumonia is caused by the fungus Pneumocystis jirovecii, which is common in the environment and can be carried in the lungs of healthy individuals without any symptoms.

The infection can spread from person to person through the air and impact immunocompromised patients, including those with medical conditions such as HIV, chronic lung diseases, cancer, and autoimmune diseases, according to the Centers for Disease Control and Prevention.

Immunocompromised Individuals at Risk

According to a risk statement issued by the FDA in its recall notice, there is a “reasonable probability” that in immunocompromised individuals, 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 the recall.

The FDA noted that any adverse reactions can be reported to the agency’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.

Alternatively, adverse reactions can be reported directly to Bionpharma Inc. via phone or email.

In the meantime, consumers who have the affected product are being asked to stop using it immediately and return it to the place of purchase.

“We take these findings seriously and are taking immediate action to address the situation,” the FDA 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.”

The FDA added that its priority remains the safety and well-being of consumers. The agency also remains committed to transparency throughout this process, it said.

Bionpharma Inc. is currently notifying its distributors and customers about the recall via email and is also arranging for the product to be returned and replaced, according to the FDA’s notice.

Distributors and retailers that have lots of the recalled product are also being asked to immediately cease distributing it and remove it from active inventory, the FDA said.