Dr Reddy’s Laboratories withdraws tizanidine tablets from US market

12 Apr 2013 Evaluate

Dr Reddy’s Laboratories has started withdrawing its muscle relaxant - tizanidine tablets, from the US market because of labeling issues. The entity has taken this decision after receiving the notification issued by United States Food and Drug Administration (FDA), and the same was intimated to the drug regulator through a letter on March 19.

The company has received the notification from FDA that, there is a possibility that the bottle labels do not contain the strength of the product as well as other printing details. Till the date 117,000 bottles are being recalled from the market by Dr Reddy’s Laboratories under a Class-III recall. The tablets are of 4 mg strength. 

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