FDA Recalls Another Batch of Generic Metoprolol

June 24th, 2014

FDA Recalls Another Batch of Generic Metoprolol

Larry Husten, PHD

The FDA has recalled more than 13,000 bottles of metoprolol succinate extended-release tablets manufactured by Dr. Reddy’s Laboratories. In addition, the agency recently recalled another lot of generic metoprolol from a different company, Wockhardt. Both recalls were for medicines manufactured at facilities in India. There have been multiple reports in recent years of problems with generic drugs made in India.

The recalls were categorized as Class II, which the FDA says “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

A story in the New York Times details the long-simmering and growing concerns of Cleveland Clinic cardiologist Harry Lever over generic metoprolol. Lever reported his concerns to the FDA and attempted to get Congress involved, but he could not prove the generics were at fault. “’You see enough people and you get a feel, but it’s anecdotes. It’s not science’,” Lever told the Times. Now, he “is feeling a sort of sad vindication,” the Times reports.

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June 24th, 2014