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 Expiry date Pack size First distributed
K1 Jun 2017 1 x 100 02 Oct 2014

Sodium Valproate Zentiva 500mg Gastro-resistant Tablets, PL 17780/0454, Zentiva Livery

Batch number Expiry date Pack size First distributed
J601 Aug 2016 1 x 100 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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Drug alert: Epilim 200/ 500mg gastro-resistant tablets/ sodium valproate zentiva 200mg/500mg - smell with foil packaging

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