The Food and Drug Administration (FDA) has issued a recall for two brands of potassium chloride capsules due to concerns that they may not dissolve properly, potentially leading to serious health risks, including heart attacks.
Glenmark Pharmaceuticals Inc. is recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, intended for patients with low potassium levels (hypokalemia). The recall is due to 'failed dissolution' in the pills, which could elevate potassium levels and increase the risk of a heart attack.
American Health Packaging has also recalled 21 batches of the same capsules, distributed by BluePoint Laboratories. The FDA warns that the failed dissolution of these capsules may cause hyperkalemia (high potassium levels), leading to irregular heartbeats, cardiac arrest, severe muscle weakness, and potentially death.
While no hyperkalemia cases or serious adverse events have been reported so far, the FDA advises consumers to discontinue use of the recalled products immediately. The capsules are typically sold in bottles of 100-count and 500-count.
Glenmark is contacting wholesale and distributor customers to facilitate the return of all recalled batches. Wholesalers and distributors are urged to halt distribution of the affected products and follow the instructions outlined in the recall letter. Additionally, they should conduct a sub-recall to notify retail or pharmacy customers.
It is crucial for individuals who have been prescribed potassium chloride extended-release capsules to check with their healthcare providers regarding alternative treatment options. The FDA emphasizes the importance of addressing this recall promptly to prevent any potential health complications.
