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A Resized Recall Image cb1August 1 2017

The MHRA has issued a Class 3 recall for Torrent Pharma UK’s Dutor (duloxetine) Gastro-resistant hard capsules.

 

 

 

Several strengths are affected: 20mg, 30mg, 40 and 60mg. The affected batches are as listed:

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 a precaution following out of specification results for dissolution being noted during routine stability testing.

Further information about stock availability is available from Lee Ford at Torrent Pharma on 01293 574184 and regarding medical information queries from Josephine Ayella on 01293 574183.

Link:
MHRA alert 

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