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
For medical information enquiries, please contact Josephine Ayella on:
01293 574183
josephine.ayella@torrentpharma.co.uk
Download document
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.