A combined 135 batches of capsules are being pulled back from consumers because the flawed medication could lead to cardiac arrest, according to officials.
Glenmark Pharmaceuticals recalled 114 batches of potassium chloride extended-release capsules and American Health Packaging — on behalf of BluePoint Laboratories — recalled 21 batches of the same capsules last week.
The voluntary recall was issued because of the failed dissolution of the capsules, which could possibly lead to high potassium levels also known as hyperkalemia, according to the companies’ announcements posted by the US Food and Drug Administration. Glenmark Pharmaceuticals had to recall 114 batches of the capsules over failure to dissolve. Google Maps
Hyperkalemia, in turn, can result in an irregular heartbeat that can open the door to cardiac arrest, the companies said.
The recall for Glenmark was issued last Monday and the recall for BluePoint was issued the following day.
The capsules are both manufactured by Glenmark, the Miami Herald reported.
To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall, the companies stated in both recalls. The drug recalls took place last week, according to an FDA notice. FDA
The capsules are intended for patients with low potassium, also known as hypokalemia. They are packed in bottles of 100 and 500.
The FDA posted the recalled batch numbers for Glenmark and BluePoint on its website.
Consumers that 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, the companies advised.
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.
