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Clarification - Simvastatin tablets - Product recall in US

| Updated on April 20, 2016 Published on April 20, 2016

Biocon Ltd has informed BSE that :

"With reference to the above recall listed by the USFDA, the Company wishes to clarify as follows -

The Class III recall for 5mg tablets of simvastatin pertains to a specific lot manufactured by Blu Caribe, Puerto Rico, USA for Blu Pharmaceuticals, Kentucky, USA (together Blu) long before Biocon acquired the simvastatin ANDA from Blu. The FDA notified Biocon as we are the current holders of the ANDA. Blu has successfully initiated and completed the recall. Biocon has not manufactured and supplied any simvastatin tablets to date."

Pdf Link: >Clarification - Simvastatin tablets - Product recall in US

Source : BSE - >www.bseindia.com

Published on April 20, 2016
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