Chest Pain Drug Withdrawn by Dr. Reddy's Laboratories From US Market

Dr Reddy's Laboratories Ltd has volunteered to withdraw 13,560 bottles of metoprolol succinate extended release tablets from the United States following the failure of dissolution tests, said the US Food and Drug Administration.

The USFDA website said, "Failed dissolution specifications: failure of dissolution test observed at 18-month time point," as the reason for recall.

The drug is used to prevent chest pain, medically known as angina, and improve survival rates after a heart attack by controlling blood pressure.

Metoprolol succinate extended release is a cheaper generic form of Toprol XL.

Dissolution tests are aimed at calculating the time taken for an active ingredient in a drug to release into the body and also assessing the drug's performance inside the body.

Wockhardt Ltd also withdrew 109,744 bottles of the said drug a month ago due to the same reason.

The withdrawal of this type is classified by the FDA as Class II, which indicates use of or exposure to the withdrawn products may cause temporary or medically reversible adverse health consequences.

Dr. Reddy's had earlier this year withdrawn about 58,656 bottles of lansoprazole, a heartburn drug, from the United States due to a microbial contamination.

A series of drug recalls have happened in the recent times due to quality issues involving Indian companies that have damaged the reputation of the industry as a cheap generic drug supplier thereby inviting stricter drug specifications from the regulators.

Source: Medindia