Bryant Ranch Prepack is recalling 4 lots of blood pressure drug Spironolactone tablets sold under BRP Pharmaceuticals brand due to mislabeling, displaying the incorrect strength, the U.S. Food and Drug Administration said.
The 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.
The recall involves Spironolactone 25 mg Tablets with NDC 63629106401, Lot # 148969; NDC 63629106402, Lot # 148791; and NDC 63629106403, Lot # 148991. All three lots have expiration date of 7/31/2022.
Further, Spironolactone 50 mg Tablets have been recalled with NDC 63629106701, Lot # 148992 and expiration date of 5/31/2022.
The product can be identified with the medication name with strength in a bold black box and a red and blue “BRP Pharmaceuticals” logo.
Spironolactone is indicated as a diuretic in the treatment of high blood pressure, heart failure, hypokalemia, and edema and is repackaged in 30, 60 and 90-count bottles.
According to the agency, a patient who consumes spironolactone 25 mg instead of the prescribed spironolactone 50 mg may experience an elevation in blood pressure or increased swelling caused by excess fluid or edema if taking the product chronically.
If taking half of the expected dose, it is possible that patients could experience a decrease in potassium which could lead to Hypokalemia, a condition associated with cardiac arrhythmias.
Further, patients who consume spironolactone 50 mg instead of the prescribed spironolactone 25 mg could experience an increase in potassium which could be life-threatening. Patients with renal insufficiency or those taking concomitant renin-angiotensin-aldosterone system or RAAS inhibitors would be at increased risk.
However, Bryant Ranch Prepack has not received any reports of adverse events related to the recall as of March 9.
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