Medicine recalls
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| The United States: Product Recall: Evicel and Evithrom |
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Ethicon, Inc is notifying customers of a manufacturing process deviation that may have potentially led to the production of vials of thrombin with decreased potency. This manufacturing deviation may affect product that was produced before December 25, 2011 and was discovered through an internal review of the manufacturing process. The FDA believes this potential decrease in potency does not pose a risk to patients as the thrombin level would still be effective in clot formation. Ethicon, Inc has not received any reports of adverse events related to this issue.
Please refer to the following website in the FDA for listing of the recalled lots and details:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/../ucm321895.htm
In Hong Kong, there are 3 registered Evicel products, namely, Evicel Solutions for Sealant 5ml (HK-61369), Evicel Solutions for Sealant 2ml (HK-61386) and Evicel Solutions for Sealant 1ml (HK-61387). They are prescription drugs and are registered by Johnson & Johnson (Hong Kong) Ltd. The company has confirmed that the products have not been imported into Hong Kong. The Department of Health has not received any reports of adverse drug reactions related to the products. There is no registered pharmaceutical product named Evithrom.
Ends/Wednesday, October 3, 2012
Issued at HKT 16:00
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