Drug Safety: the Glass Found in Ranbaxy's Generic Lipitor and Different Parties' Response
In terms of the foreign particles found in the glass-lined reactors at an active pharmaceutical ingredient plant in Toanasa, India in Nov. this year, Ranbaxy Laboratories' recall of generic Lipitor has spawned its first legal repercussion.
Then the company notified FDA this fact and the foreign particles were later identified as glass. The FDA followed up with a national announcement of the voluntary recall of the 41 lots. Then the company began to recall in early Nov. but the notice made public until two weeks later. Thus a New Jersey man has sued the Indian generics maker questioning why it took two weeks for the company to publicly notify consumers that they might be getting ground glass with their cholesterol-lowering medicine. The lawsuit points out that even then, there was only a small notice on its U.S. website.
Last week, the FDA said Ranbaxy was halting production while it determined where the problem originated and gave some explanations.