Safety Report: Potassium Chloride Extended Release Capsules - recalled due to Failed dissolution, USA

United States

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 Potassium Chloride Extended-Release Capsules being recalled were distributed nationwide to wholesale, distributor, and retail outlets.

Risk Statement: 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.

Please visit the below link to view the recalled lot numbers and expiration dates.

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. 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.

Wholesalers, distributors, and retailers that have the recalled products should discontinue distribution of the recalled product lots immediately and follow the instructions provided in the written recall letter.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: American Health Packaging
Brand name: Blue Point Laboratories
Product recalled: Potassium Chloride Extended Release 750mg Capsules, 100 count and 500 count
Reason for the recall: Failed dissolution

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-behalf-bluepoint-laboratories-issues-voluntary-nationwide-recall-potassium