The pharmaceutical landscape has witnessed several recalls initiated by the FDA due to drugs being contaminated with a spectrum of impurities, ranging from bacteria and particulates to potential carcinogens. The most recent addition to this list is VistaPharm, a Florida-based generic drug manufacturer, which is recalling a widely-used ulcer medication amid concerns of bacterial contamination.
VistaPharm has disclosed that it’s withdrawing a specific lot of its sucralfate oral suspension from the US market after discovering contamination with Bacillus cereus—a bacteria commonly linked to food poisoning. The release on the FDA’s website highlights the potential risks, particularly to immunocompromised individuals, where the bacteria’s toxins can lead to symptoms like vomiting or diarrhoea, and in severe cases, life-threatening infections such as endocarditis and necrotizing soft tissue infections.
The company’s release specified that as of September 22, there have been no reported adverse effects or safety issues associated with the recalled lot, which was slated to expire on October 31. This lot had been distributed nationwide to three distributors via wholesale channels.
This incident mirrors a similar recall by Camber Pharmaceuticals in April, wherein a batch of a pneumonia medication, atovaquone, was recalled over potential contamination with the same bacteria, marking a recurring issue within the industry.
VistaPharm is no newcomer to product recalls. In 2016, the company had to recall over 8,900 cases of oxycodone due to packaging issues that resulted in leakage. This incident followed shortly after VistaPharm, known for its specialisation in liquid generics, was acquired by Vertice Pharma.
In a subsequent turn of events, VistaPharm was acquired by PAI Pharma last fall for an undisclosed amount. This acquisition prompted organisational restructuring, including the closure of its Largo, Florida facility, leading to layoffs and relocations. VistaPharm announced that several employees had the option to move to PAI’s Greenville, South Carolina facility, alongside equipment and products, signalling further adjustments in 2023.
The series of events underscore the challenges faced by pharmaceutical companies in maintaining quality control and the ongoing vigilance required to ensure the safety and efficacy of medical products in the market. It also brings to light the evolving landscape of the pharmaceutical industry, marked by acquisitions, restructurings, and the continual need for adaptation.