Official announcements
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Recall
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Medicines
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01/02/2012
The marketing authorization holder has informed its supplied customers in a letter dated 26.01.2012 that crystalline particles may be present in the amino acid chamber of the batches listed below and that a recall is therefore being carried out as a…
Recall
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Medicines
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22/12/2011
The marketing authorization holder has informed its supplied customers in a letter dated December 21, 2011, that crystalline particles may be present in the amino acid chamber of the batches listed below and that a recall is therefore being carried…
Recall
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Medicines
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22/12/2011
In a letter dated December 12, 2011, the distribution partner informed the institutional pharmacies supplied that the marketing authorization holder was recalling those batches of "Velcade" that were produced at the manufacturer Ben Venue…
Replacement
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Medicines
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14/12/2011
The marketing authorization holder has informed its supplied customers by letter dated 14.12.2011 that the above mentioned batches have to be recalled due to a potential contamination with particles. This problem was identified during a GMP…
Recall
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Medicines
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28/11/2011
The marketing authorization holder has informed the supplied customers by letter dated November 28, 2011, that a GMP inspection of the manufacturer Ben Venue Laboratories (BVL) in Ohio/USA identified quality assurance deficiencies. As a precautionary…
Replacement
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Medicines
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25/11/2011
The distributor has informed the supplied institutional pharmacies in a letter dated November 25, 2011, that a GMP inspection of the manufacturer Ben Venue Laboratories (BVL) in Ohio/USA has identified deficiencies in quality assurance. As a…
Replacement
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Medicines
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16/11/2011
The marketing authorization holder informed its supplied customers in a letter dated November 14, 2011, that there was misinformation in the instructions for use regarding the appearance of the tablets: the description reads salmon-colored oval…
Recall
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Medicines
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08/11/2011
The marketing authorization holder informed its supplied customers in a letter dated November 7, 2011, that crystalline particles may be present in the amino acid chamber of the two batches mentioned and that a recall is therefore being carried out…
Recall
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Medicines
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04/11/2011
In a letter dated November 3, 2011, the distributor informed all pharmacies, dentists and the wholesalers supplied that all batches of this medicinal product are being recalled due to possible microbial contamination with Burkholderia…
Recall
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Medicines
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27/10/2011
The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed its supplied customers by letter dated October 27, 2011, that all batches of the product Xigris are being recalled. The reason for this withdrawal…