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Wockhardt recalls over 109,000 bottles of hypertension drug in US

LiveMint logoLiveMint 15-05-2014 Zeba Siddiqui

Mumbai: Wockhardt Ltd is recalling 109,744 bottles of a high blood pressure drug in the US after it failed a dissolution test, the US Food and Drug Administration (FDA) 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 US 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 US.

The FDA website said the recalled lots were manufactured at a Wockhardt plant in Mumbai. Reuters

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