Other safety alerts
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| The United Kingdom: Class 4 medicines defect information: Defect with Epilim/ sodium valproate gastro-resistant tablets - some batches have an odour |
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MHRA has been made aware of an unusual odour associated with some batches of Epilim / sodium valproate gastro-resistant tablets. The products involved are Epilim 200mg Gastro-resistant Tablets, PL 04425/0302, Sanofi Livery, and Epilim 500mg Gastro-resistant Tablets, PL 04425/0303, Sanofi Livery (Aventis Pharma Limited), and Sodium Valproate Zentiva 200mg Gastro-resistant Tablets, PL 17780/0453, Zentiva Livery, and Sodium Valproate Zentiva 500mg Gastro-resistant Tablets, PL 17780/0454, Zentiva Livery (Winthrop Pharmaceuticals UK Limited). Details of the batch numbers involved can be found in the MHRA's website.
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/defect-with-epilim-sodium-valproate-gastro-resistant-tablets-some-batches-have-an-odour#aventis-pharma-limited
In Hong Kong, Epilim 200 Enteric-coated Tab 200mg (HK-27293) is a pharmaceutical product registered by Sanofi-Aventis Hong Kong Limited (Sanofi), and is a prescription-only medicine. So far, the Department of Health has not received any report on unusual odour of the concerned product. As confirmed with Sanofi, the affected batches have not been imported into Hong Kong.
Ends/ Tuesday, March 31, 2015
Issued at HKT 16:00
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