Glenmark Recalls Potassium Chloride Extended-Release Capsules

Mahwah, New Jersey-based Glenmark Pharmaceuticals Inc., USA is recalling 114 batches of Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEq K citing failed dissolution, according to the U.S. Food and Drug Administration.

Potassium Chloride Extended-Release Capsules are used for the treatment of patients with low potassium (hypokalemia).

The capsules are packaged in bottles of 100-count (NDC 68462-357-01) and 500-count (NDC 68462-357-05) capsules. The recall includes products with various lot numbers and expiration dates.

The impacted capsules were distributed across the United States to wholesale, distributor, and retail outlets.

The agency noted that the failed dissolution of potassium chloride extended release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heart beat that can lead to cardiac arrest.

To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to the recall.

Wholesalers, distributors, and retailers are urged to discontinue distribution of the recalled product lots immediately.

Consumers with the capsules are asked to consult with their physician or health care provider before they stop using the product.

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