Medicine recalls
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| The United Kingdom: Company-led drug recall: Evicel solutions for sealant - Omrix Biopharmaceuticals NV - due to manufacturing issue |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announced that Omrix Biopharmaceuticals NV is recalling seven batches of Evicel solutions for sealant, package of two vials containing Human Fibrinogen and Human Thrombin (lot numbers: Q52F320, Q52F320A, Q52F320B, R05F120, R07F210A, R15F460 and R18F520). This is because a manufacturing process deviation was detected, which affected batches produced before 25 December 2011.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/../CON207199
In Hong Kong, Evicel Solutions for Sealant 5ml (HK-61369), Evicel Solutions for Sealant 2ml (HK-61386) and Evicel Solutions for Sealant 1ml (HK-61387) are registered by Johnson & Johnson (Hong Kong) Ltd. (Johnson). They are prescription-only medicines. Johnson confirmed that the products have not been imported in Hong Kong since registration obtained. News regarding the recall of Evicel has been released by the US FDA and was posted on the website of Drug Office on 3 October 2012.
Ends/ Friday, November 23, 2012
Issued at HKT 12:00
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