Medicine recalls
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| The United States: FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr |
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The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.
While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement.
As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.
At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.
Please refer to the following website in US FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/../ucm550170.htm
In Hong Kong, the above products are not registered pharmaceutical products. According to the records of the Department of Health (DH), Epipen 0.15mg and Epipen 0.3mg have been imported from the US for the treatment of particular patients by Luen Cheong Hong Ltd (LCH). As confirmed with LCH, the affected batches in the US FDA announcement have never been imported into Hong Kong. DH will monitor the development of the situation and will continue to liaise with the importers of Epipen products to provide timely updates of the situation when necessary.
Ends/ Saturday, April 1, 2017
Issued at HKT 12:00
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