The generic Lipitor that Ranbaxy Laboratories has recalled came out of an Indian plant that the FDA let out of the doghouse only 7 months ago. While it was approved to make atorvastatin imported into the U.S., it remains under the watchful eye of a phalanx of independent consultants mandated under a 5-year consent decree made with federal authorities in the U.S.
The company says in a statement on its U.S. website that the affected product may contain particles of glass smaller than 1 mm. "Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall for atorvastatin calcium tablets, in connection with its 10 mg, 20 mg, and 40 mg dosage strengths, packaged in 90 and 500 count bottles and only with respect to certain select lot numbers. The recall does not affect or relate to the 80 mg strength."
The FDA tells Bloomberg that the disruption may cause a shortage of generic Lipitor in the U.S. About 1 million prescriptions of the drug are sold each week. Mylan ($MYL) and Watson Pharmaceuticals ($WPI) also make the generic and may be able to pick up some of the slack, according to Bloomberg.
Ranbaxy only returned to importing products to the U.S. in April after the FDA approved its generic version of Lipitor being made at a plant in India that is operating under a consent decree. Ranbaxy reported a huge first quarter, in large part because its North American sales doubled during the period, to 20.93 billion rupees ($375 million). That was tied to getting an FDA signoff to manufacture and sell in the U.S. its generic version of Lipitor, made at one of its major Indian plants.
But the company has a long way to go to work its way back into the good graces of the FDA. In 2008, regulators uncovered a list of manufacturing issues and faked drug quality data, and banned 30 products from the U.S. The blueprint for that journey is laid out in the 55-page consent decree that Ranbaxy and Daiichi Sankyo, the Japanese company that owns controlling interest in Ranbaxy, entered into last year with the Department of Justice and the FDA. Among other things, Ranbaxy is required to hire data-integrity and manufacturing experts who will watch over its shoulder, make recommendations and take the issues up with the FDA.