American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.
The failed dissolution of potassium chloride extended-release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heartbeat that can lead to cardiac arrest. For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, there is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life threatening adverse events of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death. To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall.
Potassium Chloride Extended-Release Capsules are used for the treatment of patients with low potassium (hypokalemia) and are packaged in bottles of 100-count (NDC 68001-396-00) and 500-count (NDC 68001-396-03) capsules.
The Potassium Chloride Extended-Release Capsules being recalled were distributed nationwide to wholesale, distributor, and retail outlets.