Friday, May 16, 2014

INDIA - Wockhardt recalls over 1 lakh bottles of hypertension drug in US

Drugmaker Wockhardt is recalling 1,09,744 bottles of a high blood pressure drug in the United States after it failed a dissolution test, the US Food and Drug Administration has said.
The recall of metoprolol succinate began in April and was posted on the FDA website late Wednesday. Metoprolol succinate extended release is a cheaper generic form of AstraZeneca Plc's branded drug Toprol.
A Wockhardt spokesman did not immediately respond to a request for comment on Thursday.
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.
Recalls of medicines by drugmakers are not uncommon, but Wockhardt is already embroiled in regulatory troubles.
Two of its 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 those plants was making metoprolol succinate for the United States.
The FDA website said the recalled lots were manufactured at a Wockhardt plant in Mumbai.

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