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Sun Pharma's Effexor Recalled for Second Time in the US

Nov 24, 2014

According to the U.S. Food and Drug Administration (FDA), Sun Pharmaceutical Industries Ltd. has recalled the antidepressant drug Effexor for the second time in the U.S. The company recalled 68,000 bottles of the drug for failing to dissolve properly in quality tests.

This is the same issue that prompted the first recall, Wall Street Journal reports. The drug was manufactured at the same facility in the Indian generic drug maker's plant in Halol in the western state of Gujarat in both recalls. Effexor was last recalled in June.

The second recall occurs just as Sun Pharma is looking to finalize its acquisition of Ranbaxy Laboratories Ltd. Wall Street Journal reports that Ranbaxy has come under intense scrutiny over manufacturing problems in India, and is having issues removing export restrictions on its India facilities. Currently, only one of its plants is allowed to manufacture drugs to be exported to the United States. Quality issues prompted Japanese parent Daiichi Sankyo Co. to sell it in April.

According to a Credit Suisse report, the FDA raised safety concerns upon inspecting Sun Pharma's plant in April. The agency criticized the drug maker for having “no formalized corrective action plan” to prevent recalls in the future. The FDA can issue a warning letter, and later an export ban, if it is not satisfied with Sun Pharma's plants to resolve issues at the facility.

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