Class 3 Medicines Recall: Specific batches of Torrent Dutor (Duloxetine) Gastro-resistant Capsules

Torrent Pharma (UK) Ltd is recalling the below batches as a precaution because out of specification results for dissolution were obtained during routine stability testing.

Product information

PL number

PL 36687/0185

PL 36687/0186

PL 36687/0187

PL 36687/0188

MDR number

MDR 33-07/17

Company name

Torrent Pharma (UK) Ltd

Product description

Dutor 20mg Gastro-resistant Capsules, Hard

Dutor 30mg Gastro-resistant Capsules, Hard

Dutor 40mg Gastro-resistant Capsules, Hard

Dutor 60mg Gastro-resistant Capsules, Hard

(Duloxetine)

Batch number/expiry

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

Brief description of the problem

Torrent Pharma (UK) Ltd is recalling the above batches as a precaution because out of specification results for dissolution were obtained during routine stability testing.

Remaining stock of these batches should be quarantined and returned to the original supplier for credit.

For stock enquiries, please contact lee Ford on:

01293 574184

lee.ford@torrentpharma.co.uk

For medical information enquiries, please contact Josephine Ayella on:

01293 574183

josephine.ayella@torrentpharma.co.uk

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Torrent Dutor (Duloxetine) Gastro-resistant Capsules (EL (17) A/07)

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional Teams are asked to forward this to community pharmacists, relevant clinics and dispensing general practitioners. It is not necessary to forward this notice to non-dispensing GPs.

Published 31 July 2017