Sun Pharmaceutical Industries Ltd.’s U.S. subsidiary has recalled more than 428,000 bottles of antidepressant and antihistamine pills that failed to meet U.S. drug release standards, according to the U.S. Food and Drug Administration (FDA). Sun Pharma’s Caraco Pharmaceutical Laboratories Ltd. began the series of recalls in March and April that affected 251,882 bottles of Venlaxafine, a prescription drug that treats depression, and 176,176 bottles of the antihistamine Cetirizine, according to FDA enforcement reports posted on the agency’s website. The tablets failed to meet U.S. drug-release dissolution specifications, the FDA said, and Caraco recalled the Venlaxafine tablets in March and the Cetirizine pills the following month.
The recalls come months after FDA officials blackballed one of the generic drug giant’s overseas plants and as Indian drugmakers face increasingly intense scrutiny from U.S. regulators. FDA officials blackballed a Sun Pharma plant in March, saying the manufacturer’s Karkhadi, India, facility violated U.S. good-manufacturing standards. The generics maker has 24 plants, 15 of which are approved by either the FDA or European regulators and three of which are in the U.S. FDA regulators have also placed bans on six Ranbaxy Laboratories Ltd. facilities as Sun Pharma attempts to buy the struggling Ranbaxy in a $3.2 billion all-stock deal.
The FDA found that employees at Ranbaxy’s Toansa, India, plant regularly retested raw materials, intermediate drug products and finished active pharmaceutical ingredients that failed to meet specifications until they obtained “acceptable results.” Sun Pharma shareholders accused the companies of violating Indian insider trading rules. According to the petition, a Sun Pharma subsidiary bought a substantial chunk of Ranbaxy shares in the days before the deal announcement. The merged company would become India’s biggest pharmaceutical company with a presence in dozens of countries around the world, driving annual revenues past $4.2 billion. During a trip to India in February, FDA Commissioner Margaret Hamburg said the agency would increase its collaboration with Indian drug regulators after the FDA issued restrictions on the nation’s exported drugs and increased its presence there.
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