Two brands of potassium chloride capsules are being recalled because they may not dissolve as they should, which could cause a heart attack, according to the Food and Drug Administration (US Food and Drug Administration).
In a press release issued on June 25, the FDA explained that Glenmark Pharmaceuticals Inc. is recall of 114 lots of a product called Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K. The reason is the “failure to dissolve” the pills.
The product is intended for patients who suffer from low potassium levels or hypokalemia.
According to the FDA, a failed dissolution could elevate consumers’ potassium levels to the point where a heart attack could occur.
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The FDA has announced the recall of two different drugs that, due to a failure to dissolve, can potentially cause heart attacks. (iStock)
American Health Packaging issued a similar recall of 21 lots of the same capsules. The capsules were also manufactured by Glenmark but distributed by BluePoint Laboratories.
“Failure to dissolve potassium chloride extended-release capsules may result in high potassium levels, also known as hyperkalemia, which can cause an irregular heart rhythm that can lead to cardiac arrest,” the FDA statement said.
“In patients who require chronic use of potassium chloride extended-release oral capsules…there is a reasonable likelihood of developing hyperkalemia which may lead to a range of adverse events of varying severity, from asymptomatic to more serious life-threatening adverse events related to hyperkalemia, such as cardiac arrhythmias, severe muscle weakness, and death,” the agency added.
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The product is intended for patients who suffer from low potassium levels or hypokalemia. (FDA)
The FDA also noted that no cases of hyperkalemia or “serious adverse reactions” have been reported to date in connection with the product. The statement noted that the capsules are sold in bottles of 100 and 500 capsules.
“Glenmark is notifying its wholesale and distributor customers by written letter and arranging for the return of all recalled lots,” the FDA said. “Wholesalers, distributors, and retailers who have the recalled products should immediately stop distributing the recalled product lots and follow the instructions provided in the written recall letter.”
“Wholesalers and distributors should conduct a sub-recall to retail customers or pharmacies.”
Glenmark Pharmaceuticals Inc. is recalling 114 lots of a product called Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K. (iStock)
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Fox News Digital has reached out to Glenmark Pharmaceuticals Inc. for comment but has not received a response.
