Defect with Epilim/ sodium valproate gastro-resistant tablets - some batches have an odour
(Aventis Pharma Limited and Winthrop Pharmaceuticals UK Limited) The smell associated with some batches is said to be a result of the foil packaging, but patients should continue taking their medicine. (EL (15)A/02)
30 March 2015
Class 4 medicines defect information
Caution in use
Distribute to pharmacy level
MDR 09-03/15
Product details
Aventis Pharma Limited
Epilim 200mg sastro-resistant Tablets, PL 04425/0302, Sanofi Livery
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| J601 | Aug 2016 | 1 x 100 | 23 Oct 2014 |
| J602 | Aug 2016 | 1 x 100 | 12 Nov 2014 |
| J603 | Aug 2016 | 1 x 100 | 03 Dec 2014 |
| K1 | Jun 2017 | 1 x 100 | 29 Dec 2014 |
| K2 | Sep 2017 | 1 x 100 | 09 Jan 2015 |
| K3 | Sep 2017 | 1 x 100 | 06 Feb 2015 |
| K7 | Sep 2017 | 1 x 100 | 05 Jan 2015 |
Epilim 500mg Gastro-resistant Tablets, PL 04425/0303, Sanofi Livery
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| J602 | Aug 2016 | 1 x 100 | 19 Dec 2014 |
| J603 | Aug 2016 | 1 x 100 | 06 Jan 2015 |
| K1 | Jun 2017 | 1 x 100 | 22 Jan 2015 |
| K2 | Jun 2017 | 1 x 100 | 06 Feb 2015 |
Winthrop Pharmaceuticals UK Limited
Sodium Valproate Zentiva 200mg Gastro-resistant Tablets, PL 17780/0453, Zentiva Livery
- Batch number: K1
- Expiry date: Jun 2017
- Pack size: 1 x 100
- First distributed: 02 Oct 2014
Sodium Valproate Zentiva 500mg Gastro-resistant Tablets, PL 17780/0454, Zentiva Livery
- Batch number: J601
- Expiry date: Aug 2016
- Pack size: 1 x 100
- First distributed: 01 Oct 2014
Alert details
MHRA has been made aware of an unusual odour associated with the above batches of Epilim / sodium valproate gastro-resistant tablets. The odour has variously been described as ‘fishy’, ‘sweaty armpits’ and ‘cannabis’. An investigation by Sanofi has identified the root cause as the aluminium foil used in the packaging of affected batches. No impact on the quality or efficacy of the tablets has been detected. Sanofi has now ceased using this foil supplier.
In order to avoid product shortages which could impact on current advice not to switch between different manufacturers for this product, the above batches are not being recalled. Patients should therefore be advised to continue taking their medication. It may be necessary to distribute additional batches packed in the same foil in order to keep the market supplied. Batches packed in foil sourced from an alternative supplier are expected to be available by the end of April 2015 and distribution of impacted batches will cease at this time.
For all enquiries about this matter, please contact Sanofi Medical Information on 0845 3727101 or email UK-medicalinformation@sanofi.com.
Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.
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