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Class 3 recall for Torrent Dutor (Duloxetine)

Routine stability tests note dissolution rate changes

August 2nd 2017

Tagged: MHRA alert

By Charles Gladwin

Several batches of Torrent Pharma’s Dutor (duloxetine) Gastro-resistant Capsules, Hard, are in a Class 3 drugs recall issued on Monday.

The affected batches are as follows:

Strength Batch Number Expiry Date Pack Size First Distribution
20mg BAC5C001 31 Oct 2017 1 x 56 Jun 2016
20mg BAC5C002 31 Jul 2018 1 x 28 Jan 2017
20mg BAC5C005 31 Aug 2018 1 x 28 Feb 2017
30mg BAC3C001 31 Oct 2017 1 x 28 Sep 2016
30mg BAC3C002 31 Oct 2017 1 x 28 Jun 2016
30mg BAC3C007 31 Aug 2018 1 x 28 Feb 2017
40mg BAC4C001 31 Oct 2017 1 x 56 Jun 2016
40mg BAC4C004 31 Aug 2018 1 x 56 Jan 2017
60mg BAC6C001 31 Oct 2017 1 x 28 Jun 2016
60mg BAC6C003 31 Jul 2018 1 x 28 May 2017

The recall is precautionary as routine stability testing found dissolution rates were outside of the normal specifications.

Affected stock should be quarantined and returned to the original supplier for credit.

Further information can be obtained from Torrent Pharma – contact Lee Ford on 01293 574184 for stock enquiries or Josephine Ayella on 01293 574183 for medical information.

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