Medicine recalls
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| The United Kingdom: Class 2 medicines recall (action within 48 hours): Ebixa 5mg/pump actuation 50ml and 100ml bottle manufactured by Lundbeck Limited |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announced that Lundbeck Limited is recalling specific batches of Ebixa 5mg/pump actuation 50ml and 100ml bottles. This is because of a fault with some of the pump devices which may result in suboptimal dosage of the product. MHRA understand that no immediate or major hazard for the patient is expected however it cannot be excluded that individual patients may potentially experience worsening of their condition from under-dosage.
The affected batches of Ebixa 5mg/pump actuation 50 ml bottle are 363530, 363729, 364381, 364620, 364639, 365766, 366902, 369095, 370325, 471986, 473236 and 474349. The affected batches of Ebixa 5mg/pump actuation 100 ml bottle are 364384, 365579, 366903, 369090, 370328, 471112, 471266, 473233, 474348 and 476354. The only unaffected stock currently available is the 50ml bottle but Lundbeck Limited is working closely with its suppliers to bring stocks of 100ml bottles to the market as quickly as possible.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/Publications/Safetywarnings/../CON491151
In Hong Kong, Lundbeck Export A/S (Lundbeck) registered the above product as Ebixa Oral Drops 10mg/g (HK-51936). As confirmed by Lundbeck, the product has never been sold on the Hong Kong market.
Ends/ Friday, December 19, 2014
Issued at HKT 13:00
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