More than 100 batches of a medication are being recalled due to a fault that could potentially lead to hyperkalemia, irregular heartbeats and even cardiac arrest. Glenmark Pharmaceuticals is voluntarily recalling its blood pressure medication due to failed dissolution, when the capsules don't dissolve correctly, interfering with the extended-release mechanism of the medication.
Specifically, the recall affects 114 batches of Potassium Chloride Extended-Release 750mg Capsules, in both 100 count and 500 count packs. Consumers are advised to consult their doctor before discontinuing use of the product or if they experience any issues that may be related to it.
The company has issued the recall amid concerns that the capsules may not dissolve properly, leading to high potassium levels. While potassium is often used in the treatment of high blood pressure, excessive amounts can have serious side effects.
The FDA shared the announcement, noting that elevated potassium levels, or hyperkalemia, can result in irregular heartbeats and potentially even cardiac arrest. For those who rely on the capsules as a long-term medication, particularly those with underlying health conditions such as hypertension, heart failure or renal dysfunction, the company warned: "There is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events."
These "adverse events" include: "cardiac arrhythmias, severe muscle weakness, and death". However, the notice emphasised that there have been no reports of hyperkalemia or "serious adverse events" in relation to the recall.
Glenmark Pharmaceuticals released a list of the specific batch numbers and expiration dates of the bottles involved in the voluntary recall in a document distributed by the FDA. American Health Packaging has voluntarily recalled 21 batches of the same medicine on behalf of BluePoint Laboratories.
The FDA is also encouraging people to report any adverse events to its MedWatch Adverse Event Reporting program via mail, fax or online.