The drug repackaging business provides a convenient way for doctors and pharmacies to dispense tailor-made doses to patients—but when a drug turns up in a mismarked container, it's a potentially serious problem.
Pharmaceutical repackager Bryant Ranch Prepack recalled three lots of 25-mg spironolactone tablets and one lot of 50-mg spironolactone tablets after a labeling mix-up. The 50-mg bottles may contain 25-mg tablets and vice versa, the company said in an FDA notice posted Tuesday.
Bryant Ranch's recall notice didn’t say how it identified the packaging glitch and the company wasn't immediately available for comment.
The company says it re-packages spironolactone—used to treat high blood pressure, heart failure, hypokalemia and edema—in 30-, 60- and 90-count bottles. The three suspect 25-mg lots carried an expiration date of July 31, 2022, while the 50-mg lot bears an expiration date of May 31, 2022. The company didn’t say how many total bottles the recall covers.
As of March 9, Bryant Ranch said it hadn’t received any side effect reports linked to the recall. Patients who take spironolactone regularly could suffer a spike in blood pressure or increased swelling from fluid retention if they take a lower dose than prescribed, the company said. Potassium levels could also decrease if they mistakenly take half the expected dose, which could cause hypokalemia, which itself may cause irregular heartbeat.
On the flip side, patients who take a higher dose than expected could suffer a life-threatening increase in potassium. Patients with poor kidney function or those on renin-angiotensin-aldosterone system inhibitors—used to treat hypertension, heart failure and certain types of chronic kidney disease—are at greater risk, the company added.
The company is contacting distributors and customers nationwide to get the recalled product back.
The FDA allows certain groups like state-licensed pharmacies, federal facilities and outsourcing firms to re-package drugs into different containers, so long as no changes are made to the products themselves. Bryant Ranch does repackaging work for resale to physicians and clinics, which allows doctors to dispense drugs to patients on-site.