Glenmark Pharmaceuticals Faces Recalls and Safety Concerns Over Potassium Chloride Pills
The FDA Hasn’t Inspected This Drug Factory After 7 Recalls for the Same Flaw, 1 Potentially Deadly 🔗
Glenmark Pharmaceuticals, an Indian drug manufacturer, has faced multiple recalls of its potassium chloride pills due to a critical flaw that could potentially be deadly. Despite seven recalls for similar issues over the past year, the FDA has not inspected the factory responsible for these drugs, raising concerns about the agency's oversight of foreign drug manufacturers. Reports of three patient deaths and serious health problems associated with the recalled pills have emerged, although it remains unclear if the drugs were the direct cause. The FDA's delayed response and lack of transparency about the recalls highlight ongoing challenges in ensuring drug safety from overseas production facilities.
Why hasn't the FDA inspected Glenmark's factory after the recalls?
The FDA has not visited the Glenmark factory despite multiple recalls due to an apparent lack of urgency in addressing the ongoing issues, even though the last inspection occurred over four years ago.
What issues have been reported with the recalled potassium chloride pills?
The recalled potassium chloride pills did not dissolve properly, which could lead to dangerously high potassium levels in patients, potentially resulting in serious health risks, including cardiac arrest.
What actions has Glenmark taken in response to the recalls?
Glenmark has acknowledged the recalls and reported instances of deaths and hospitalizations associated with the recalled pills but has denied responsibility for the claims in a federal lawsuit.