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Metoprolol, Generic Version of Toprol, Recalled After Failing Dissolution Test

Filed May 16th, 2014 Laurie

Wockhardt Ltd. is recalling 109,744 bottles of metoprolol, the generic version of AstraZeneca’s drug, Toprol, after the affected bottles failed a dissolution test.

The U.S. Food and Drug Administrator (FDA) has given the recall a Class II label, which indicates that use of or exposure to the affected drug could cause temporary adverse health events, TheHinduBusinessLine.com explained.

Tablet dissolution is a standardized method used for testing how quickly a drug is released from a dosage form. According to TheHinduBusinessLine.com, the drugs in the recalled bottles failed the dissolution test at the nine-month time point.

The affected bottles contain 30, 50-mg metoprolol succinate extended-release tablets that were manufactured by Wockhardt. The drugs were distributed in the U.S. by Woackhardt USA Ltd., TheHinduBusinessLine.com reported.

Last year, the FDA launched a $20 million program to test generic drugs to find out if they are truly an equivalent to their brand-name counterparts. The agency announced earlier this month that it was in the process of testing metoprolol succinate extended release, according to Fierce Pharma.

FDA Spokeswoman Sandy Walsh announced earlier this month that the agency had rethought the criteria it uses to approve generic drugs, which make up about 80 percent of the prescriptions written in the U.S. India produces about 40 percent of the generic drugs used in this country, which has raised concerns among health officials over foreign companies’ quality standards, Fierce Pharma reported.

A Bloomberg analysis of adverse effects reports revealed that generic drugs accounted for more than 3,400 of the adverse event reports submitted to the FDA, Fierce Pharma reported.

In the last year, the FDA has banned Wockhardt plants in Chikalthana, as well as in Waluj, India. The Chikalthana plant was also made metroprolol succinate before it was banned, according to Fierce Pharma.

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