A California drug company has issued a voluntary recall of a medication used to treat high blood pressure and certain hormone issues due to a labeling error.
The nationwide recall issued by Bryant Ranch Prepack (BRP Pharmaceuticals) includes 47 bottles of spironolactone tablets — particularly bottles of 50 mg strength and 25 mg strength. According to the FDA, the 50 mg labels and 25 mg labels were incorrectly placed on the wrong bottle.
By taking less than prescribed strength, the FDA says some patients may experience an elevation in blood pressure, and it is possible patients could develop Hypokalemia — a condition associated with heart arrhythmia. Patients taking more than the prescribed amount of spironolactone could experience a life-threatening increase in potassium.
As of Tuesday, BRP Pharmaceuticals has not received any reports of adverse events related to the labeling error.
The following lots are included in the recall:
|Product Description||NDC||Lot # (Expiration Date)|
|Spironolactone 25 mg Tablets||63629106401||148969 (7/31/2022)|
|Spironolactone 50 mg Tablets||63629106701||148992 (5/31/2022)|
Customers can contact BRP Pharmaceuticals at 877-885-0882 Monday through Friday between 9:30 a.m. to 9 p.m. ET. Customers should contact their physicians with they experience any problems taking the medication.