FDA – The U.S. Food and Drug Administration issued a safety alert concerning a blood pressure drug with a labeling error that could cause ‘life-threatening’ overdoses and deaths. According to the recall announcement, Bryant Ranch Prepack has issued a nationwide recall of its Spironolactone 25 mg and 50 mg blood pressure medications due to a mislabeling error that lists the incorrect strength.
Spironolactone is a medication that is used to treat patients who suffer high blood pressure, excess fluid retention (edema), low potassium (Hypokalemia), and heart failure. The recall is potentially deadly, and therefore, the FDA classified the recall as a Class I recall.
Bryant Ranch Prepack, a distributor of Spironolactone, has recalled four lots of the blood pressure drug that was sold by the company nationwide. Bryant Ranch Prepack stated in their FDA-posted recall notice that the company’s prepackaged bottles of Spironolactone 50 mg could actually contain its lower dose Spironolactone 25 mg tablets. The mislabeling also affects its prepackaged bottles of Spironolactone 25 mg, which may actually contain the higher dose of 50 mg Spironolactone tablets.
If a patient prescribed 25 mg tablets of Spironolactone but accidentally took the 50 mg Spironolactone tablets, Bryant Ranch states, the patient might experience a life-threatening increase in potassium. Patients who take the medication for their renal insufficiency or patients taking concomitant renin-angiotensin-aldosterone system (RAAS) inhibitors are at an increased risk of severe injuries or death.
If a patient is prescribed 50 mg doses of Spironolactone, the lower 25 mg dose of Spironolactone could cause the patient to experience increased swelling caused by excess fluid (edema) or a serious elevation in blood pressure. A patient may also suffer irregular heartbeats related to Hypokalemia.
Bryant Ranch’s recall affects the following lots:
- 25 mg Spironolactone tablets, lot No. 148969, 30-count bottles; No. 148791, 60-count bottles; and No. 148991, 90-count bottles, all with expiration dates of 7/31/2022; and
- 50 mg Spironolactone tablets, lot No. 148992, 30-count bottles, with an expiration date of 5/31/2022.
The product is identifiable by the following characteristics on the label: The medication name is listed with the strength in a bold black box. The box also has a red and blue “BRP Pharmaceuticals” logo.
Bryant Ranch Prepack is reporting the recall to its distributors and customers by mail and is planning for the return of all recalled products. Distributors are advised to return all existing inventory of the lots listed above and contact Bryant Ranch Prepack immediately.
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