Granules is recalling more than 33,000 bottles of hypertension drug Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, in the U.S. market.
It is a voluntary, firm-initiated recall on account of failed dissolution specifications. The product failed to meet dissolution acceptance criteria in the stability studies at the 6th month, the U.S. Food and Drug Administration (U.S. FDA) said in its latest enforcement report.
Granules Pharmaceuticals Inc is recalling 27,648 100-count bottles and 5,376 500-count bottles of the drug manufactured by Granules India, Hyderabad.