Sunday, March 9, 2014

And the saga continues...

Per this news report, Ranbaxy has now withdrawn over 64,000 bottles of atorvastatin, the generic form of Lipitor, due to a mix-up in dosages. According to the FDA, a pharmacist found a 20 milligram tablet of atorvastatin in a sealed bottle meant to contain 10 milligram tablets of the drug. This, after all of Ranbaxy's India-based manufacturing plants have been shut down, and their only plant now supplying generic drugs to the US market is the New Jersey-based Ohm Laboratories Inc.

The error has been classified by the FDA as a Class II recall, which means that it most probably would not result in any adverse events - people are not likely to get very sick or die by taking twice as much of the drug as they should. Also, the recall was voluntary, and not imposed by the FDA or any other regulatory body.

Nonetheless, this kind of mistake still looks bad for a company hit with very serious questions about its quality control process. Ranbaxy is already under a cloud, and news of this sort is certainly not helping to restore consumer faith.

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