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THE PHARMA REVIEW (JULY – AUGUST 2014)

Drug Recalls Due To Dissolution Failures: What Can Be Done?

Ravindra Chenny

Introduction: Recall is an action taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative or by FDA, MHRA request/ order. Pharmaceuticals companies such as Sun Pharma, Wockhardt, Dr. Reddy's to name a few, have faced such drug recalls from the US FDA recently, as few of their anti-depressant, anti-cancer, anti-diabetes and hypertension drugs did not meet the “drug release dissolution specifications” during the long term stability studies. 

 

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