Medicine recalls
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| The United Kingdom: Company-led drug recall: Herceptin 150 mg powder for concentrate for solution for infusion - Roche Products Limited - as a small number of vials are suspected of having being falsified |
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Roche Products Limited is recalling the following batches of Herceptin (batch no.: H4311B07, H4319B02, H4271B01, H4143B01, H4329B01, H4324B03, H4301B09, H4284B04, H4196B01 and H4303B01) to wholesale level in the UK as a precautionary measure, as a small number of vials are suspected of having being falsified. None of the batch numbers listed above have been distributed by Roche Products Ltd to the UK market. These batches were packed and distributed by Roche to the Italian market. Material that was subsequently offered for sale by parallel importers outside of Italy is being recalled. Product that has been distributed directly to hospitals by Roche Products Ltd is not affected by the issue.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/../CON406386
In Hong Kong, Herceptin Powder & Solvent for Inj 440mg (HK-50617), Herceptin Powder for Inj 150mg (HK-50618) and Herceptin Powder for Inj 150mg (Germany) (HK-56694) are registered pharmaceutical products which are registered by Roche Hong Kong Limited (Roche), and they are prescription only medicines. Related news was released by the EMA and was posted on the Drug Office website on 17 April 2014 and today (22 April 2014). As confirmed with Roche, the affected batches have not been imported into Hong Kong. The Department of Health will keep vigilant against the captioned issue.
Ends/ Tuesday, April 22, 2014
Issued at HKT 14:00
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