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2/22/2013 7:29:05 AM
Last November, Ranbaxy Laboratories recalled more than three dozen lots of generic Lipitor because some contained tiny glass particles and the generic drugmaker then halted all production of the cholesterol pill. Not surprisingly, the move prompted lawsuits, even though the FDA indicated the likelihood of patient harm appeared to be “extremely low.” But several consumers are asking a federal judge to order a complete recall and Ranbaxy is arguing vociferously against such a move. And as part of its argument, the generic drugmaker – which is already operating under a consent decree because of serious manufacturing problems – is questioning the credibility of several of the consumers who say they suffered harmful side effects after taking its version of Lipitor. Before we continue, some background: the November 9 recall was made at the pharmacy level, which means consumers were not directly notified or told how to respond if they became aware. And Ranbaxy did not make any public statement until a brief notice – with a link to a list of recalled lots – was placed on its web site on November 23, prompting media coverage. A press release was not issued until November 28. And while the lots were not made in plants cited in the consent decree, Ranbaxy initially refused to discuss the source of the damaged product. The FDA, meanwhile, intially advised consumers who were concerned about their supplies to stop taking the pill and seek alternatives. A day later, though, the agency then advised consumers that they could continue taking the Ranbaxy version of Lipitor unless their physician instructed them otherwise.
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