FDA Classifies Nationwide Recall of Blood Pressure Drug Ramipril

The U.S. Food and Drug Administration (FDA) has classified a nationwide recall of over 28,000 bottles of the blood pressure medication ramipril as a Class II recall. Hikma Pharmaceuticals USA Inc. voluntarily initiated the recall on August 24, with the FDA designation coming on September 3. The recall is due to failed impurity and degradation specifications, specifically an out-of-specification result for a process impurity.