A blood pressure drug has been recalled after a possibly ‘life-threatening’ mistake
A distributor of Spironolactone recalled four lots sold nationwide in reaction to a packaging mistake that endangers users of the drug.
“Prepackaged bottles labeled Spironolactone 50 mg may contain Spironolactone 25 mg tablets and prepackaged bottles of Spironolactone 25 mg may contain Spironolactone 50 mg tablets,” Bryant Ranch Prepack said in their FDA-posted recall notice.
Spironolactone is used to treat high blood pressure, heart failure, excess fluid retention (edema) and low potassium (hypokalemia).
A person prescribed 25 mg tablets and who takes 50 mg, Bryant Ranch says, “could experience an increase in potassium which could be life-threatening. Patients with renal insufficiency or those taking concomitant renin-angiotensin-aldosterone system (RAAS) inhibitors would be at increased risk.”
A person prescribed 50 mg doses and taking 25 mg “may experience an elevation in blood pressure or increased swelling caused by excess fluid (edema) if taking the product chronically.” Also, irregular heartbeats related to hypokalemia are possible.
So, Bryant Ranch has pulled bottles labeled for 25 mg tablets, lot No. 148969, 30-count bottles; No. 148791, 60-count bottles; and No. 148991, 90-count bottles, all with expiration dates of 7/31/2022; and No. 148992, 30-count bottles of 50 mg tablets with expiration date of 5/31/2022.
If this or any other drug causes a medical problem, after notifying a medical professional, let the Food and Drug Administration know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
Those with questions about the recall can call Bryant Ranch at 877-885-0882, Monday through Friday, 9:30 a.m. to 9 p.m., Eastern time.
This story was originally published March 10, 2021 at 12:38 PM.
