Official announcements
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Replacement
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Medicines
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14/11/2012
The distributor informed its supplied customers in a letter dated November 14, 2012, that a deviation in the manufacturing process, which was identified during an internal audit, may result in a reduced efficacy of the product. The potential…
Safety warnings
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Medicines
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09/11/2012
The batches of Fluad and Sandovac influenza vaccines that were temporarily suspended two weeks ago due to a suspected quality defect (white particles in the bulk vaccine) were re-released on Nov. 9, 2012.
Recall
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Medicines
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29/10/2012
The marketing authorization holder informed its supplied customers in a letter dated October 24, 2012, that there is a possible pyrogen contamination in the two batches listed above.
Recall
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Medicines
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16/10/2012
The marketing authorization holder, in consultation with the French authority, informed its supplied customers by letter dated 10/10/2012 that batch C079 is being recalled because it has a different volume/activity indication on the bottle label…
Recall
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Medicines
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25/09/2012
Sanofi Pasteur MSD GmbH has informed its supplied customers in a letter dated 24.09.2012 that a voluntary recall is being carried out for the above-mentioned batches due to a possibly too low antigen content.
Recall
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Medicines
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05/09/2012
The parallel distributor, HAEMATO PHARM AG; has informed its supplied customers by letter dated 5.9.2012 that the batches placed on the market by him are recalled, because tablets were found which are light blue and have "GILEAD" as tablet embossing.…
Replacement
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Medicines
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27/08/2012
The marketing authorization holder informed its supplied customers in a letter dated August 27, 2012, that in the course of stability tests at the manufacturer Ben Venue Laboratories, Ohio, USA, an overfill was detected in a single dry-stone ampoule…
Replacement
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Medicines
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13/08/2012
The distribution partner sanofi-aventis GmbH Austria informed its supplied customers by letter dated August 13, 2012, that aggregates above the specification limit of 5% occurred after reconstitution of reserve samples of a batch sold in the USA. As…
Medicines
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08/08/2012
Misleading wording in package insert, see related file.
Medicines
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06/08/2012
Packaged finished product batches as of May 2011 contain incorrect information in the package insert, see associated file.