A total of 135 batches of capsules are being recalled from consumers due to concerns that the defective medication could potentially trigger cardiac arrest, as per official reports.
Last week, Glenmark Pharmaceuticals initiated the recall of 114 batches of potassium chloride extended-release capsules, while American Health Packaging, acting on behalf of BluePoint Laboratories, recalled 21 batches of the same capsules.
The voluntary recall was prompted by the discovery of issues related to the capsules’ dissolution process, raising fears of elevated potassium levels leading to hyperkalemia, as highlighted in the companies’ notifications published by the US Food and Drug Administration.
The companies have cautioned that hyperkalemia, which can result from high potassium levels, may cause an irregular heartbeat, posing a risk of cardiac arrest.
Glenmark issued its recall on a Monday, with BluePoint following suit the next day. Both sets of capsules are produced by Glenmark, as reported by the Miami Herald [1].
As stated in both recalls, “To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall.”
These capsules are meant for patients experiencing low potassium levels, also referred to as hypokalemia, and are typically packaged in bottles of 100 and 500.
The FDA has published the list of recalled batch numbers for Glenmark and BluePoint [2] on its official website.
In light of the recall, the companies have advised consumers with the affected Potassium Chloride Extended-Release Capsules to seek guidance from their physician or healthcare provider before discontinuing the product’s use.
Additionally, consumers are urged to get in touch with their healthcare provider if they have encountered any issues that could be linked to the consumption or use of this medication.