March 9, 2021
Bryant Ranch Prepack has issued a voluntary recall of 47 bottles of Spironolactone tablets in 25mg and 50mg dosage strengths. The recalled product may be mislabeled, with bottles marked as containing 25mg tablets instead containing 50mg tablets, while and bottles marked as containing 50mg tablets may in fact contain 25mg tablets.
Spironolactone is indicated to treat high blood pressure, heart failure, hypokalemia (low blood potassium levels), and edema (swelling due to excess fluid trapped in the body’s tissues). A patient who takes a 25mg dose when a 50mg dose was prescribed may experience an increase in blood pressure or swelling. They might also develop low potassium, which can contribute to cardiac arrhythmias. A patient who takes a 50mg dose when a 25mg dose was prescribed could have a life-threatening increase in potassium levels. The risk may be higher for patients who take the wrong spironolactone dose and have renal insufficiency or who are also taking a type of medication known as a renin-angiotensin-aldosterone system (RAAS) inhibitor. Bryant Ranch Prepack has not received any reports of adverse events as of the date of the recall.
Consumers should contact Bryant Ranch Prepack with questions regarding the recall at 1-877-885-0882. If a patient experiences any problems that may be related to use of the recalled product, they should contact their healthcare provider. Adverse events can also be reported to the U.S. FDA’s MedWatch program.
A full copy of the recall announcement can be found on the FDA’s website.
There is no member impact through Benecard Central Fill.