135 Batches of Medication Recalled Over Cardiac Arrest Risk: FDA

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 A total of 135 batches of capsules are being recalled due to a defect that could lead to cardiac arrest, according to officials.

Last week, Glenmark Pharmaceuticals recalled 114 batches of potassium chloride extended-release capsules, while American Health Packaging, on behalf of BluePoint Laboratories, recalled 21 batches of the same capsules.

The voluntary recall was issued due to the capsules’ failed dissolution, which can cause elevated potassium levels, or hyperkalemia, as announced by the companies and posted by the US Food and Drug Administration (FDA).

Hyperkalemia can result in an irregular heartbeat, potentially leading to cardiac arrest, the companies explained.

Glenmark’s recall was issued last Monday, followed by BluePoint’s recall the next day. Both sets of capsules are manufactured by Glenmark, as reported by the Miami Herald.

“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.

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The capsules, used to treat low potassium levels (hypokalemia), are packaged in bottles of 100 and 500.

The FDA has posted the recalled batch numbers for Glenmark and BluePoint on its website.

“Consumers with Potassium Chloride Extended-Release Capsules subject to the recall should consult with their physician or healthcare provider before discontinuing use,” the companies advised. 

“Consumers should also contact their physician or healthcare provider if they have experienced any issues potentially related to this medication.”

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