Medicine recalls
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| The United States: American Health Packaging on behalf of BluePoint Laboratories issues voluntary nationwide recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K due to failed dissolution |
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The US Food and Drug Administration (FDA) announces that 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. For details of the affected batch numbers, please refer to the website in FDA.
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 arrhythmias, 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 refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-behalf-bluepoint-laboratories-issues-voluntary-nationwide-recall-potassium
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Jun 27, 2024
Issued at HKT 16:45
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