Official announcements
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Recall
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Medicines
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15/03/2012
The marketing authorization holder informed its supplied customers in a letter dated March 15, 2012, that a degradation product of the active ingredient cinchocaine hydrochloride exceeded the specification limit during the period of use and that a…
Recall
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Medicines
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09/03/2012
The marketing authorization holder has informed its supplied customers in a letter dated March 2, 2012, that the packages of the batches listed above contain a non-updated package insert. Since e.g. changes of the side effect profile as well as a new…
Replacement
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Medicines
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01/03/2012
The marketing authorization holder informed its supplied customers by letter dated 01.03.2012 that the above batch was mistakenly delivered in sachets with the label "Dr. Kottas Husten-Bronchialtee". Both the outer packaging and the thread label show…
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…