Ranbaxy Laboratories is investigating whether splintered glass from the lining of a reactor at a plant in India is the source of particles found in the raw ingredients for generic Lipitor that were delivered to a Ranbaxy plant in the U.S. where the pills are finished.
Venkat Krishnan, who heads Ranbaxy's Americas business, told The Wall Street Journal that the company is looking into one of the glass-lined reactors at an active pharmaceutical ingredient plant in Toansa, India, which makes some of the ingredients for Ranbaxy's atorvastatin. Some of the pills are manufactured in India and some at a plant in New Brunswick, NJ, Krishnan told the newspaper. He said a quality check on the raw ingredient at the New Brunswick plant in late September discovered the foreign particles, and so the company notified the FDA. An independent lab identified them as glass.
The company then undertook a recall of 41 lots, most of which Krishnan said never made it beyond the wholesale level. The company started the recall in early November, but a notice did not go out to the public until two weeks later. Last week, the FDA said Ranbaxy was halting production while it determined where the problem originated.
Ranbaxy did tell the newspaper that it has received one report of an adverse event but does not yet know if it is tied to the recalled product. A lawsuit has also been filed against the generics maker over the recall.
- read the Wall Street Journal story (sub. req.)