Effoxor Recalled For a 2nd Time This Year

 

Sun Pharmaceutical Industries Ltd. has recalled 68,000 bottles of the antidepressant Effexor (venlafaxine), in the second recall of the drug this year, the Food and Drug Administration (FDA) said.

In both instances, the recalled drug was manufactured at the Indian generic drug maker’s plant in Halol in the state of Gujarat. The drugs were recalled after they failed to dissolve properly in quality tests. The earlier recall, in June, was for 252,000 bottles of Effexor.

Sun Pharma is attempting a $3.2 billion purchase of Ranbaxy Laboratories, an Indian drug manufacturer that has been under scrutiny for manufacturing problems. Ranbaxy has been under export restrictions on its facilities in India, leaving it with only one plant able to manufacture drugs that can be shipped to the U.S. market. The plant in Halol has come under scrutiny from the FDA after a series of recalls of drugs manufactured there, including the diabetes drugs metformin. The FDA inspected Sun Pharma’s plant in September and the agency criticized the company for having “no formalized corrective action plan” to prevent future recalls. If the FDA is not satisfied with Sun Pharma’s plans to resolve the problems found at the plant, it can issue a warning letter, and impose an export ban on the factory.

U.S. regulators are increasing scrutiny of generic drugs made in India, after a series of recalls of prescription and over-the-counter medicines made by Indian drug companies. The FDA is concerned that the drugs fail to meet U.S. standards. Dr. Margaret Hamburg, the FDA commissioner, made a nine-day visit to India in February to meet with pharmaceutical makers to discuss quality and safety issues. Indian companies supply about one quarter of the medicines used in the U.S. In 2013, the FDA banned imports from four plants belonging to Ranbaxy Laboratories Ltd. and Wockhardt Ltd.