A mixed 135 batches of capsules are being pulled again from customers as a result of the flawed treatment may result in cardiac arrest, in response to federal officers.
Glenmark Prescription drugs recalled 114 batches of potassium chloride extended-release capsules and American Well being Packaging — on behalf of BluePoint Laboratories — recalled 21 batches of the identical capsules final week.
The voluntary recall was issued due to the failed dissolution of the capsules, which may probably result in excessive potassium ranges also called hyperkalemia, in response to the US Meals and Drug Administration.
The drug recollects passed off final week, in response to an FDA discover. FDA
Hyperkalemia, in flip, may end up in an irregular heartbeat that may open the door to cardiac arrest, the FDA mentioned.
The recall for Glenmark was issued final Monday and the recall for BluePoint was issued the next day.
The capsules are each manufactured by Glenmark, the Miami Herald reported.
“Thus far, the agency has not obtained any stories of hyperkalemia or critical adversarial occasions from spontaneous sources associated to this recall,” the FDA acknowledged in each recollects.
The capsules are meant for sufferers with low potassium, also called hypokalemia. They’re packed in bottles of 100 and 500.
The FDA posted the recalled batch numbers for Glenmark and BluePoint on its web site.
“Customers which have Potassium Chloride Prolonged-Launch Capsules topic to the recall ought to seek the advice of with their doctor or well being care supplier earlier than they cease utilizing the product,” FDA officers suggested.
“Customers also needs to contact their doctor or healthcare supplier if they’ve skilled any issues that could be associated to taking or utilizing this drug product.”