Official announcements
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Recall
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Medicines
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04/06/2012
The distribution company has informed its supplied customers in a letter dated 01.06.2012 that there is a potential problem with the dispensing time and dispensing volume after the autoinjector has been triggered. This problem has arisen during the…
Recall
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Medicines
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05/04/2012
The distributor has informed its supplied customers in a letter dated April 5, 2012, that the sterility of the batches listed above can no longer be guaranteed and therefore a recall is being carried out as a precautionary measure.
Recall
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Medicines
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02/04/2012
The marketing authorization holder has informed its supplied customers in a letter dated April 2, 2012, that a microbiological contamination has been detected at the manufacturer during a routine media filling in the production line for ViaSpan and…
Recall
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Medicines
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02/04/2012
The marketing authorization holder has informed its supplied customers by letter dated April 02, 2012, that an internal stability test after 15 months of storage has revealed the occurrence of visual particles. The recall affects all dose forms of…
Recall
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Medicines
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22/03/2012
The marketing authorization holder has informed its supplied customers in a letter dated March 22, 2012, that glass splinters were found in the product vials during routine quality control. Therefore, the above mentioned batches are recalled in…
Replacement
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Medicines
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20/03/2012
The distribution company Novartis Pharma GmbH has informed its supplied customers in a letter dated March 19, 2012, that due to water ingress in the manufacturer's warehouse, a batch of the injection syringes included in the Rabipur vaccine kit has…
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…