Combination blood pressure drug recalled after failed quality test
More than 3,500 bottles of a generic blood pressure medication have been recalled after a failed quality test. This includes certain 30- and 90-count bottles of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets manufactured by Macleods Pharmaceuticals in India and distributed by its New Jersey-based subsidiary, Macleods Pharma USA.
The recall was first initiated on Oct. 7 due to “failed dissolution specifications.” This means tablets tested by a regulatory body did not break down correctly, creating a risk of the drug being less effective than intended.
On Oct. 26, the U.S. Food and Drug Administration (FDA) categorized this as a Class II recall. This means using the drug “may cause temporary health consequences, but the probability of a serious health issue is remote.”
Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets represent a combination of medications commonly prescribed to treat hypertension. Olmesartan medoxomil is an angiotensin II receptor blocker, amlodipine is a calcium channel blocker and hydrochlorothiazide is a thiazide diuretic/water pill. These tablets first gained recognition years ago when they were manufactured by Daiichi Sankyo Company and sold under the brand name Tribenzor. This recall impacts a generic version of that combination drug.
One lot included in this recall includes 3,528 30-count bottles. The other lot includes 216 90-count bottles. All medications had an expiration date of May 31, 2027.
Click here for additional details from the FDA.
A recent history of blood pressure drug recalls
In May, 675 bottles of enalapril maleate tablets were recalled due to a failed organic impurities test. One month later, more than 11,000 bottles of chlorthalidone tablets were recalled due to failed dissolution specifications. In August, meanwhile, Novartis recalled a single lot of valsartan for the same reason.
Finally, in September, more than 28,000 bottles of ramipril capsules were recalled due to an out-of-specification test result associated with dicyclohexylurea.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.