Mumbai, May 15: Wockhardt is recalling from the US 1,09,744 bottles of metoprolol — a drug to fight hypertension. The drug, belonging to multiple lots, has failed a dissolution test, the US Food and Drug Administration (US FDA) said on its website.
A dissolution test measures the time taken for a drug to get absorbed by the human body.
According to a notification by the USFDA, the class II recall is voluntary and was initiated by the company from April 1.
Class II signifies a remote chance of severe adverse health consequences because of the product flaw.
Metoprolol is a generic version of AstraZeneca Plc’s branded drug Toprol.
Bottles of metoprolol succinate extended-release tablets of 50mg dose were manufactured by Wockhardt, Mumbai, and distributed in the US by Wockhardt USA LLC.
The development had its impact on the Wockhardt scrip, which ended 2.26 per cent lower at Rs 776.45 on the Bombay Stock Exchange today.
The FDA had earlier barred two Wockhardt facilities at Chikalthana and Waluj in Aurangabad from exporting drugs to the US.
Drug recalls are, however, not a new phenomenon in the US with even some of the overseas firms resorting to such a practice.