FDA Issues Recall of 135 Batches of Potassium Chloride Capsules Amid Concerns Over Cardiac Arrest Risks

In response to potential cardiac arrest risks, federal officials have issued a voluntary recall of 135 batches of capsules. The recall, initiated by Glenmark Pharmaceuticals and American Health Packaging on behalf of BluePoint Laboratories, involves 114 batches of potassium chloride extended-release capsules by Glenmark and 21 batches of the same capsules by American Health Packaging.

The recall was prompted due to flaws in the medication’s dissolution, which could lead to high potassium levels or hyperkalemia. Hyperkalemia can cause irregular heartbeats that may eventually result in cardiac arrest. According to the US Food and Drug Administration (FDA), there have been no reports of hyperkalemia or any serious adverse events related to the recall from spontaneous sources.

Glenmark initiated its recall last Monday, with BluePoint following suit the next day. Both companies manufacture the same capsules, as reported by the Miami Herald. Consumers who have the recalled Potassium Chloride Extended-Release Capsules are advised to consult their physician or healthcare provider before stopping the use of the product.

The FDA has listed the recalled batch numbers for both Glenmark and BluePoint on its website. It is crucial for consumers to stay informed and take necessary precautions to ensure their health and safety. FDA officials recommend that consumers contact their healthcare provider if they have experienced any problems connected to taking or using this drug product.