A significant recall of over 100 batches of a specific blood pressure medication, Potassium Chloride Extended-Release 750mg Capsules, has been initiated by Glenmark Pharmaceuticals. The recall is due to concerns that the medication may not dissolve properly, potentially leading to high potassium levels (hyperkalemia) in consumers. This condition can cause irregular heartbeats and, in severe cases, may result in cardiac arrest.
The recall affects both 100 count and 500 count packs of the medication. Consumers are advised to consult their doctors if they experience any issues potentially related to the medication or if they decide to discontinue its use. It’s important to note that while potassium is often used in the treatment of high blood pressure, excessive amounts can have serious side effects.
The recall was initiated due to fears that the capsules may not dissolve properly, which could lead to high potassium levels. This issue is particularly concerning for those who rely on the capsules as a long-term medication, especially those with underlying health conditions such as hypertension, heart failure, or renal dysfunction. The company warns that there is a reasonable probability of developing hyperkalemia, which could lead to a range of severity of adverse events including cardiac arrhythmias, severe muscle weakness, and death.
However, the company has emphasized that no incidents of hyperkalemia or serious adverse events have been reported in connection with the recall. Glenmark Pharmaceuticals has publicly disclosed the specific batch numbers and expiry dates of the bottles implicated in the recall, which are also listed by the FDA.
In a separate recall, American Health Packaging withdrew 21 batches of the same medication on behalf of BluePoint Laboratories. The FDA is also encouraging individuals to report any untoward effects through the MedWatch Adverse Event Reporting program, which accepts submissions via post, facsimile, or online.