Potassium chloride drugs recalled due to 'solubility failure'

According to the Food and Drug Administration (FDA), two brands of potassium chloride capsules are being recalled because they may not dissolve properly, which could cause a heart attack.

In a press release issued on June 25, the FDA explained that Glenmark Pharmaceuticals Inc. is recalling 114 lots of a product called Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K. The reason is that the pills do not dissolve properly.

The product is intended for patients suffering from low potassium levels, also known as hypokalemia.

According to the FDA, failure to dissolve can raise potassium levels in consumers' blood to the point where a heart attack is possible.

VIRAL HOSTAGE BANDS SLEEP TREND GAINING STEAM AS DOCTORS WARN OF POTENTIAL DANGERS

The FDA has announced that two different medications are being recalled. These medications do not dissolve and can therefore cause heart attacks. (iStock)

American Health Packaging has issued a similar recall of 21 lots of the same capsules. The capsules were also made by Glenmark, but distributed by BluePoint Laboratories.

“Failure to dissolve extended-release potassium chloride capsules can lead to high potassium levels, also known as hyperkalemia, which can cause an irregular heartbeat that could lead to cardiac arrest,” the FDA statement said.

“For patients requiring chronic use of extended-release potassium chloride oral capsules… there is a reasonable risk of developing hyperkalemia, which can lead to a range of serious adverse events ranging from asymptomatic to more serious, potentially life-threatening adverse events of hyperkalemia, such as cardiac arrhythmias, severe muscle weakness, and death,” the agency said.

MORE AMERICANS SMOKE MARIJUANA DAILY THAN DRINK ALCOHOL, SURVEY SHOWS

The product is intended for patients suffering from low potassium levels, also known as hypokalemia. (Food and Health Service)

The FDA also noted that there have been no reports of hyperkalemia or “serious adverse events” related to the product. The statement noted that the capsules are sold in bottles of 100 and 500.

“Glenmark is notifying its wholesale and distributor customers via written letters 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 in the written recall letter.”

“Wholesalers and distributors must issue a recall to retail or pharmacy customers.”