Granules India Recalls Blood Pressure Medication Over Manufacturing Issues

Drug firm Granules India is undertaking a large-scale recall of its blood pressure lowering medication in the United States, prompted by manufacturing deficiencies. The company is recalling 33,024 bottles of Metoprolol Succinate tablets after failing to meet critical quality standards in stability tests.

This recall pertains to the product failing to meet dissolution acceptance criteria at the six-month mark in stability studies, the US Food and Drug Administration reported. The affected lot was manufactured in India and distributed by US-based Granules Pharmaceuticals Inc.

The USFDA classifies this as a Class II recall, suggesting that while the likelihood of serious adverse health consequences is minimal, exposure could lead to temporary or medically reversible outcomes. Meanwhile, Granules India's shares were slightly down following the announcement.

(With inputs from agencies.)