IGMPI India

Wockhardt Limited is voluntarily recalling 109,744 bottles of anti-hypertensive (high blood pressure) drugs in the US market after it failed the dissolution test, the US Food Drug Administration has said. Toprol XL, metoprolol succinate extended release is a cheaper generic form of AstraZeneca Plc's branded drug Toprol.

Wockhardt Ltd. is a pharmaceutical and biotechnology company engaged in manufacturing formulations, biopharmaceuticals, nutrition products, vaccines and active pharmaceutical ingredients (APIs). The company’s two Indian manufacturing plants were banned last year from exporting to the United States after the FDA found violations of manufacturing standards that the agency believed could compromise the quality of drugs. One of these plants was engaged in manufacturing of Metoprolol succinate for the United States.

The recalled drug, Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, were manufactured at Wockhardt plant in Mumbai. Dissolution tests are usually carried out 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 FDA has classified this recall as Class II recall, 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.