Dissolution Problems Prompt Recall by Dr. Reddy's

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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