Urgent recall of two potassium chloride drugs

Two brands of potassium chloride extended-release capsules are being recalled because they might not dissolve, posing a threat of cardiac arrest - FDA

The extended-release capsules don’t dissolve

Two brands of potassium chloride extended-release capsules are being recalled because they might not dissolve, posing a threat of cardiac arrest. 

Glenmark Laboratories recalled 114 batches of its 750 mg capsules, saying the failed dissolution of potassium chloride extended-release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heartbeat that can lead to cardiac arrest. 

“For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, there is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life-threatening adverse events of hyperkalemia such as cardiac arrhythmias, severe muscle weakness, and death,” the company warned. 

American Health Packaging has issued a similar recall of 21 batches of the same capsules, also made by Glenmark but distributed by BluePoint Laboratories. The drugs are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68001-396-00) and 500-count (NDC 68001-396-03) capsules.

The recalled potassium chloride extended-release capsules were distributed nationwide to wholesale, distributor, and retail outlets.

What to do

Consumers who have potassium chloride extended-release capsules subject to the recall should consult with their physician or health care provider before they stop using the product. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers taking the drugs from BluePoint Laboratories can find the lot numbers of the recalled capsules here. Lot numbers of the recalled Glenmark Laboratories drugs can be found here.

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