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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 July 2017

• Message type: Medicines recall/notification
• Medical specialty: Anaesthetics, Cardiology, Care home staff, Cosmetic surgery and Critical care
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• Issued: 31 July 2017

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

Download document

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