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ACETYLCYSTEINE Drug Information Page

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

ProductSourceDateLinkData
ACETYLCYSTEINEMHRA2010-6-28ACETYLCYSTEINE-MHRA-2010-6-28Replacement for Alert issued on the 24 of June.Acetylcysteine black particles have been found in a very small number of ampoules . Investigation has confirmed that the particles comprise carbonised material. In order to avoid stock shortages, these batches are not being recalled
ACETYLCYSTEINEMHRA2010-6-24ACETYLCYSTEINE-MHRA-2010-6-24Acetylcysteine black particles have been found in a very small number of ampoules . Investigation has confirmed that the particles comprise carbonised material. In order to avoid stock shortages, these batches are not being recalled
ACETYLCYSTEINEMHRA2009-11-26ACETYLCYSTEINE-MHRA-2009-11-26Aurum Pharmaceuticals Limited have informed us that there is an error in the patient information/professional leaflet contained in all batches of Acetylcysteine 200mg/ml Injection 10ml currently on the market. The error concerns the dose to be given to children weighing 20kg or more and appears in the third stage of dosing which is infused over 16 hours. To avoid stock disruption, distribution of affected stock will continue. The leaflet is being amended and it is anticipated that stock containing the corrected version will be supplied to the market by April 2010. Once corrected stock is available, distribution of product containing the affected leaflet will cease. Further information For further enquiries, please telephone Carol Akinola, Pharmacovigilance and Medical Information Manager, Aurum Pharmaceuticals Limited on 01708 382791. Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter.

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