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| The United States: Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength (English only) |
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The United States Food and Drug Administration (FDA) announces that Bryant Ranch Prepack is voluntarily recalling in total 47 bottles of Spironolactone tablets (four different lots) to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. 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.
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 (edema) if taking the product chronically. It is possible that patients could experience a decrease in potassium if taking half of the expected dose which could lead to hypokalemia, a condition associated with cardiac arrhythmias. Furthermore, 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 (RAAS) inhibitors would be at increased risk. As of 9 March 2021 Bryant Ranch Prepack has not received any reports of adverse events related to this recall. 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. The affected lots of the products are detailed below:
Spironolactone 25 mg Tablets (lot number: 148969, 148791, 148991)
Spironolactone 50 mg Tablets (lot number: 148992)
The product can be identified by the medication name with strength in a bold black box and a red and blue “BRP Pharmaceuticals” logo on the label. Bryant Ranch Prepack is notifying its distributors and customers by mail and is arranging for return of all recalled products.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-issues-voluntary-nationwide-recall-spironolactone-25-mg-and-50-mg-tablets-due
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Thursday, March 11, 2021
Issued at HKT 14:45
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