MUMBAI, June 19 (Reuters) - India’s Dr Reddy’s Laboratories Ltd is recalling 13,560 bottles of the high blood pressure drug metoprolol succinate in the United States after it failed a dissolution test, the U.S. Food and Drug Administration said.
Metoprolol succinate extended release is a cheaper generic form of AstraZeneca Plc’s Toprol XL. Wockhardt Ltd also recalled 109,744 bottles of the same drug last month citing the same reason.
The recall was voluntarily started by Dr Reddy’s on May 23, 2014, and posted on the FDA website on Thursday.
A Dr Reddy’s spokesman did not immediately respond to a request for comment on the recall.
Dissolution tests are commonly conducted to check the time taken for the active ingredient in a drug to release into the body, and help predict how the drug performs inside the body.
The Dr Reddy’s recall, like the one by Wockhardt, was classified by the FDA as Class II, which means use of or exposure to the recalled products may cause temporary or medically reversible adverse health consequences.
This is the latest in a string of drug recalls and manufacturing quality-related issues involving Indian companies that have hurt the reputation of the industry as a supplier of cheap generic drugs, and led to increased scrutiny from regulators.
Dr Reddy’s recalled about 58,656 bottles of the heartburn drug lansoprazole in the United States in March due to a microbial contamination. (Reporting by Zeba Siddiqui in Mumbai; Editing by Sunil Nair)