Generics maker VistaPharm recalls ulcer med on bacteria contamination fears
2023-09-25
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来源: FiercePharma
As of Sept. 22, VistaPharm had not received any reports of side effects or safety signals tied to the recalled batch.
Drugs tainted with impurities ranging from bacteria and particulates to likely cancer agents have triggered multiple FDA recalls in recent years. Now, Florida’s VistaPharm is pulling a popular ulcer treatment from U.S. shelves thanks to a new contamination scare.
VistaPharm revealed it’s recalling one lot of sucralfate oral suspension because the liquid drug is contaminated with Bacillus cereus, a bacterium often associated with food poisoning. Bacillus cereus produces toxins that can cause vomiting or diarrhea, and it poses an even greater risk to immunocompromised patients, VistaPharm said in a release on the FDA’s website Friday.
If an immunocompromised individual were to take some of the suspect sucralfate, there is a “reasonable probability” that microbial contamination of the medication could cause “disseminated, life threatening” infections like endocarditis—when the inner lining of the heart valves and chambers becomes inflamed—or necrotizing soft tissue infections, which can destroy skin, muscle and other soft tissues, the company said.
As of Sept. 22, VistaPharm had not received any reports of side effects or safety signals tied to the recalled batch.
The affected lot of sucralfate oral suspension was set to expire on October 31. It was shipped out across the U.S. to three distributors by wholesale, VistaPharm said.
When it comes to microbial contamination, Camber Pharmaceuticals found itself in a similar bind this past April, when it recalled one batch of the pneumonia drug atovaquone over the potential presence of Bacillus cereus—the same bacterium behind VistaPharm’s new market withdrawal.
As for VistaPharm, the company is no stranger to the recall game. Back in 2016, the company yanked more than 8,900 cases of oxycodone after finding that excess material had gathered between the seal and the cup containing the medicine, resulting in leakage. That packaging snafu came just a few months after VistaPharm, which specializes in production of liquid generics, was bought out by Vertice Pharma.
Last fall, meanwhile, VistaPharm changed hands once more when it was bought by PAI Pharma for an undisclosed sum. In tandem with that deal, VistaPharm in October said it would close up shop in Largo, Florida, and lay off 36 of its 177 full-time workers, with more cuts to come in 2023. Some of the VistaPharm workers had the option to relocate—along with equipment and products—to PAI’s facility in Greenville, South Carolina, the company said at the time.
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