ComplianceOnline

Ranbaxy recalls Sotret in the US for second time

  • Date: November 25, 2009
  • Source: www.in-pharmatechnol
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Ranbaxy has recalled its acne treatment drug Sotret for the second time owing to some descrepancy in the specifications. This is deemed as more of a voluntary and precutionary move as per the FDA class III procedure. In 2008, FDA had banned this drug owing to GMP deviations observed in Ranbaxy production plant in Himachal Pradesh. Ranbaxy was recently bought over by Japanese DaiiChi Sankyo who were surprised by the observation of filing untrue data by Ranbaxy with the FDA. Both the companies are cautious that this will not derail their ongoing efforts of reversing the ban in the US. Since the ban, the drug has lost heavily in the US market in terms of revenue.

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