Urgent withdrawal of two potassium chloride drugs

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

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

“For patients requiring chronic use of oral potassium chloride extended-release capsules, particularly in those patients with comorbidities or conditions that cause alterations in potassium excretory mechanisms such as hypertension, heart failure, or renal dysfunction, there is a probability reasonable to develop hyperkalemia that can lead to a range of severity of adverse events from being asymptomatic to the more severe potentially 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 to treat patients with low potassium levels (hypokalemia) and are packaged in 100-count (NDC 68001-396-00) and 500-count (NDC 68001-396-03) capsule bottles.

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

What should be done

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

Consumers who receive medications from BluePoint Laboratories can find the lot numbers of the recalled capsules here. Many numbers of drugs recalled by Glenmark Laboratories can be found here.