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AMIODARONE HYDROCHLORIDE Drug Information Page

Updated 11/08/2010 12:12:41 AM

ProductSourceDateLinkData
AMIODARONE HYDROCHLORIDEMHRA2010-1-5AMIODARONE HYDROCHLORIDE-MHRA-2010-1-5Following our Class 4 Caution in Use notice issued on 23 December 2009 (EL (09)A/36) and further discussions with Aurum Pharmaceuticals, all remaining stock of the above two batches is now being recalled from hospitals, wholesalers and relevant clinics
AMIODARONE HYDROCHLORIDEMHRA2009-12-23AMIODARONE HYDROCHLORIDE-MHRA-2009-12-23Aurum Pharmaceuticals have informed us that particles have been found in some ampoules of batch 80593 but in addition batch 80604 is being included as a precautionary measure. An investigation is in progress to determine the nature of the particles and the root cause of the problem. The SPC describes this product as 'a clear pale yellow solution practically free from particulates'. Provided this product is inspected as per normal parenteral practices any unsuitable ampoules should be detected and discarded.

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