Safety Report: Spironolactone TB 25MG, 50MG - recalled due to incorrect strength, USA

United States

Company name: Bryant Ranch Prepack
Brand name: BRP Pharmaceuticals
Product recalled: Spironolactone TB 25MG and 50MG
Reason of the recall: Incorrect strength displayed on the label
FDA Recall date: March 09, 2021
Recall details: Company Announcement Bryant Ranch Prepack is voluntarily recalling 4 lots of Spironolactone tablets 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 3/9/2021 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. Lots included in recall:

- Spironolactone 25 mg Tablets. NDC. 63629106401. Lot # (Expiration Date): 148969 (7/31/2022).
- Spironolactone 25 mg Tablets. NDC. 63629106402. Lot # (Expiration Date): 148791 (7/31/2022).
- Spironolactone 25 mg Tablets. NDC. 63629106403. Lot # (Expiration Date): 148991 (7/31/2022).
- Spironolactone 50 mg Tablets. NDC. 63629106701. Lot # (Expiration Date): 148992 (5/31/2022).

The product can be identified by the following details on the label: Medication name as listed above with strength in a bold black box and a red and blue “BRP Pharmaceuticals” logo.

Bryant Ranch Prepack is notifying its distributors and customers by mail and is arranging for return of all recalled products. Distributors that have existing inventory of any of the lots listed in this recalled should contact Bryant Ranch Prepack immediately.

Consumers with questions regarding this recall can contact Bryant Ranch Prepack at 877-885-0882 Mon.-Fri. 6:30am-6pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-issues-voluntary-nationwide-recall-spironolactone-25-mg-and-50-mg-tablets-due

Source: FDA