FDA Announces Recall of Drug of Possible Contamination That Can Cause ‘Life Threatening Infections’

The U.S. Food and Drug Administration in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images

Camber Pharmaceuticals said it recalled some of its pneumonia medicine after it discovered the drug may be contaminated with the Bacillus cereus bacteria, according to a U.S. Food and Drug Administration (FDA) announcement.

The voluntary recall impacts one lot of Atovaquone Oral Suspension, USP in either 750-milligram or 5-milliliter doses to the consumer level due to possible contamination, the March 31 announcement said. The drug is meant to prevent and treat pneumonia caused by Pneumocystis jiroveci, a type of fungus that can cause infections in adults and teens who can’t tolerate other drugs.

“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 endocarditis and necrotizing soft tissue infections,” the notice said.

But so far, the New Jersey-based company has not received any “reports of adverse events related to this recall,” the announcement said.

The drug was distributed across the United States to retail pharmacies, mail-order pharmacies, and wholesalers. The product is packaged in a 210-milliliter “HDPE bottle in a mono carton,” it said. The identified National Drug Code, or NDC, associated with the product is 31722-629-21, while the UPC is  331722629218, and the affected lot number is E220182 with an expiration date of December 2023.

“Camber Pharmaceuticals, Inc. is notifying its distributors and customers by our Reverse Logistics Company, Inmar, by mailings and emails communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP,” the notice said.

As for consumers who have the drug, they are advised to either return the medication to the place of purchase, discard it, and contact their doctor, according to the FDA announcement.

Those with adverse reactions or quality problems in connection to the drug can report them to the  FDA’s MedWatch Adverse Event Reporting system. People with questions regarding this recall can contact Inmar by phone at 1-877-597-0878 or email [email protected].

Meanwhile, consumers should contact their physician or medical provider if they have experienced any health issues that they suspect are related to the product.

While the recall notice did not provide further details about the possible Bacillus cereus contamination, the bacteria is considered a foodborne pathogen that can produces gastrointestinal illnesses, including vomiting and diarrhea. According to the U.S. Department of Agriculture in a report (pdf), it can be “easily spread to many types of fresh and processed food products” such as meat, vegetables, milk, and other common food products.

“It does not usually pose a health risk. Illness usually occurs when food is improperly cooked and stored in the danger zone (41ºF to 135ºF) for an extended period of time,” it says.

Noting examples of outbreaks of the infection, the USDA said that “in 2014 in China, 139 people reported nausea, vomiting, and diarrhea after consuming fermented black beans” contaminated with the bacteria. And, it added, “Another severe outbreak occurred in 2003, in Leuven, Belgium, where five children in one family became ill after consuming pasta salad that contained the emetic toxin.”

Other Recalls

In late March, the FDA announced a recall of  Dabigatran Etcxilate Capsules at the consumer level after nitrosamine, a carcinogenic substance, was discovered above the “acceptable daily intake level.”  The company said it hasn’t received any reports of adverse events or health problems in connection to the medication.

“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” the FDA advised. “The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.”

Several weeks before that, Sun Pharmaceuticals confirmed it is voluntarily recalling diltiazem hydrochloride in a 360-milligram dosage form across the United States. Diltiazem hydrochloride is used to treat chest pain, high blood pressure, and some heart rhythm disorders like atrial fibrillation or rapid heartbeats.

And before that, Aurobindo Pharma USA announced the voluntary recall of two lots of blood pressure medication because of high levels of nitrosamine, according to a separate FDA notice.