Glenmark Pharmaceuticals has announced a voluntary recall of 114 batches of its 750 mg potassium chloride extended-release capsules due to failed dissolution tests.
This defect could result in hyperkalemia, a potentially life-threatening increase in potassium levels, especially in patients with conditions like hypertension or renal dysfunction. The affected products were manufactured at a facility in Madhya Pradesh, India and distributed nationwide in the U.S.
Hypokalemia, the condition treated by these capsules, refers to a lower-than-normal level of potassium in the bloodstream. Potassium is vital for many bodily functions, including the regulation of heart and muscle function, and the transmission of nerve signals. Insufficient potassium can cause symptoms such as weakness, fatigue, muscle cramps, and irregular heartbeats, and in severe cases, it can be life-threatening due to the potential impact on heart rhythm.