US: Glenmark Pharmaceuticals, BluePoint Laboratories Recall 135 Batches of Blood Pressure Capsules Over Cardiac Arrest Fear
This recall, announced last week, is due to a dissolution failure that could lead to hyperkalemia, a condition characterized by high potassium levels, according to the US Food and Drug Administration (FDA).
New York, July 1: In a significant move, Glenmark Pharmaceuticals and American Health Packaging, on behalf of BluePoint Laboratories, have issued a voluntary recall of a combined 135 batches of potassium chloride extended-release capsules. This recall, announced last week, is due to a dissolution failure that could lead to hyperkalemia, a condition characterized by high potassium levels, according to the US Food and Drug Administration (FDA).
According to the New York Post report, the FDA warned that hyperkalemia can cause irregular heartbeats, potentially leading to cardiac arrest. Despite the recall, no reports of hyperkalemia or serious adverse events have been received so far. Dr Reddy’s, Sun Pharma and Aurobindo Pharma Recall Products in US Due to Manufacturing Issues.
135 Batches of Capsules Recalled Due to Potential Cardiac Risks in US
Glenmark Pharmaceuticals is recalling 114 batches, while American Health Packaging is recalling 21 batches. The capsules, which are used to treat hypokalemia or low potassium levels, are packaged in bottles of 100 and 500.
Patients using potassium chloride extended-release capsules to manage high blood pressure and prevent heart or kidney failure are at significant risk due to a recent recall. The compromised dissolution of these pills could lead to hyperkalemia, a condition marked by high potassium levels, which can cause cardiac arrhythmias, severe muscle weakness, and even death. US Pizza Recall Alert: Frozen Meat Pizzas Distributed to Grocery Stores Including Walmart Recalled Due to Soy Allergy Risk.
Glenmark Pharmaceuticals, which manufactures the capsules, has not yet received any reports of hyperkalemia or related adverse events. However, the affected batches have already been distributed nationwide to wholesale, distributor, and retail outlets. In response, Glenmark has issued letters to these customers, instructing them to remove the products from their shelves immediately.
Patients prescribed these recalled batches are advised to consult their doctors before discontinuing use. Additionally, Glenmark recommends that consumers contact their healthcare providers if they experience any symptoms of hyperkalemia.
The FDA has posted the batch numbers for the recalled products on its website. Consumers in possession of these capsules are advised to consult their healthcare providers before discontinuing use. Additionally, any adverse effects experienced should be reported to a healthcare professional immediately.
(The above story first appeared on LatestLY on Jul 01, 2024 01:09 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).