Dissolution Problems Prompt Recall by Dr. Reddy's

June 19, 2014
Pharmaceutical Technology Editors

Dr. Reddy's recalls blood pressure drug due to failed dissolution tests.

FDA has reported that Dr. Reddy’s Laboratories has initiated a voluntary recall for Metoprolol Succinate Extended Release Tablets, USP 25 mg, 100-count bottle for failed dissolution specifications.

The recall, initiated on May 23, 2014, involves 13,560 bottles, was for failure of a dissolution test observed at an 18-month time point and involved two lots.

FDA classified the recall as Class II, a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Source: FDA

 

 

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