The Food and Drug Administration on Tuesday upgraded a recall of a generic version of blood pressure medication metoprolol to its second-highest level because it failed to meet the FDA’s own criteria.
The recall notice encompasses metoprolol succinate extended-release tablets in 25 milligram doses in 100-count and 500-count bottles. India-based Granules Pharmaceuticals Inc., the manufacturer, voluntarily recalled the medication, which is a beta-blocker used to treat high blood pressure, heart failure, and angina, or chest pain.
Both recalled lots, or roughly 33,000 bottles, have an expiration date of Dec. 31, 2025. They were also distributed throughout the United States, according to the notice.
The FDA said the reason for the recall is that the “product failed to meet dissolution acceptance criteria in the stability studies at the 6th month.”…