More than 100 batches of a particular medication are being recalled due to concerns that they could lead to hyperkalemia, irregular heartbeats and even cardiac arrest.
Glenmark Pharmaceuticals is voluntarily recalling its blood pressure medication due to failed dissolution.
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 potentially related to it.
The company has issued the recall amid fears 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, highlighting that high 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”.
The notice emphasised that no incidences of hyperkalemia or “serious adverse events” have been reported in connection with the recall.
Glenmark Pharmaceuticals publicly disclosed the specific batch numbers and expiry dates of the bottles implicated in the recall, identifying them in a list provided by the FDA.
In a separate recall initiated by American Health Packaging, 21 batches of the same medication were withdrawn from the market on behalf of BluePoint Laboratories.
Additionally, the FDA is calling on individuals to report any untoward effects through the MedWatch Adverse Event Reporting programme which accepts submissions via post, facsimile or online.