Bryant Ranch Prepack is voluntarily recalling four lots of a blood pressure medication called Spironolactone due to a packaging mistake which resulted in bottles displaying the incorrect strength.
Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets, while prepackaged bottles of spironolactone 25 mg may contain Spironolactone 50 mg tablets, according to the company-written, FDA-posted recall notice.
Why It Could Potentially Be Life-Threatening
The U.S. Food and Drug Administration said the drug — which is used to treat high blood pressure, excess fluid retention (edema), heart failure, and low potassium (hypokalemia), was packaged in bottles with incorrect strengths printed on them.
With this, we can see how important medicine labels are. Even the slightest error in dosage and information can endanger the lives of patients.
For instance, in a number of Elmiron lawsuits filed, plaintiffs who were prescribed Elmiron for their interstitial cystitis have complained of suffering from maculopathy and other vision problems after several years of taking the drug to treat their cystitis.
According to some claims, patients were not warned by the manufacturer of possible side effects like vision problems, retinal damage, and eventually, vision loss.
This is because the company did not include these rare yet serious side effects on Elmiron’s original label. Now, plaintiffs are seeking justice for the injuries they have sustained from the medication.
In the case of Spironolactone, however, here’s why a packaging mistake can potentially be fatal:
Patients who ingest a stronger dose of the blood pressure medication than what they were prescribed could suffer from adverse consequences.
For instance, a person prescribed with 25 mg tablets but mistakenly took 50 mg “could experience an increase in potassium which could be life-threatening,” Bryant Ranch said.
Conversely, a person prescribed with 50 mg doses but ended up taking 25 mg tablets “may experience an elevation in blood pressure or increased swelling caused by excess fluid (edema) if taking the product chronically,” the company added.
Furthermore, “patients with renal insufficiency or those taking concomitant renin-angiotensin-aldosterone system (RAAS) inhibitors would be at increased risk,” Bryant Ranch also stated in the recall notice.
Lots Included In The Recall
Spironolactone is repackaged in 30, 60, and 90-count bottles.
The company-initiated recall applies to bottles with expiration dates of 7/31/2022 and 5/31/2022, mainly with 25 mg and 50 mg tablets.
Of the 25 mg tablets, lot numbers 148969, 148791, and 148991 have been recalled. Meanwhile, of the 50 mg tablets, lot number 148992 has been pulled from the market.
The product can be identified by looking for the medication name with the strength in a bold black box as well as a red and blue “BRP Pharmaceuticals” logo.
What You Can Do
Bryant Ranch said that it is notifying customers affected by the recall through mail.
If you have questions regarding this recall, you can contact Bryant Ranch Prepack at 877-885-0882 Mon.-Fri. 6:30 A.M.-6:00 P.M. PST.
More importantly, reports of adverse reactions related to the use of the recalled Spironolactone tablets should be directed to the FDA’s MedWatch Adverse Event Reporting program.