Official announcements
Recall
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Medicines
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12/09/2014
Gedeon Richter Austria GmbH" informed its supplied gynecologists in a letter dated September 10, 2014, that instabilities were detected in the affected physician sample batch, which could shorten the shelf life and therefore no further distribution…
Recall
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Medicines
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11/09/2014
The parallel distributor informed its supplied customers on 10.09.2014 that the batches originating from Romania had been illegally introduced into the legal distribution chain and that the product may therefore no longer be used. These batches were…
Recall
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Medicines
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11/09/2014
The parallel distributor informed its supplied customers on 10.09.2014 that the batches originating from Romania had been illegally introduced into the legal distribution chain and that the product may therefore no longer be used. These batches were…
Safety warnings
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Blood & Tissue
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08/09/2014
The Federal Office for Public Health Safety was informed by the Romanian authority that a new confirmed case of human WNV infection (neuro-invasive disease) was recorded in Romania, Scanteia (Ialomiţa county).
Safety warnings
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Blood & Tissue
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05/09/2014
The Federal Office for Safety in Health Care was informed that the first confirmed WNV infection was recorded in Austria in 2014.
Recall
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Medicines
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04/09/2014
The marketing authorization holder informed its supplied customers in a letter dated September 3, 2014 that aflatoxin contamination was detected in processed extract batches of passionflower herb during follow-up testing of reserve samples, which…
Recall
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Medicines
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04/09/2014
In a letter dated September 3, 2014, the marketing authorization holder informed its customers that aflatoxin contamination had been detected in follow-up tests on dried passionflower extract.
Recall
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Medicines
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03/09/2014
The parallel distributor informed its supplied customers on 03.09.2014 that a counterfeit had occurred in the batch originating from Romania, which was identified by optical deviations on the stopper and the missing flip-off cap of a piercing bottle.
Safety warnings
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Blood & Tissue
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03/09/2014
The Federal Office for Public Health Safety has been informed by the Romanian authority that the first human WNV (neuro-invasive disease) infections have been recorded in Romania. The affected areas are Focşani (Vrancea county), Corabia (Olt county), and Ungheni city (Mures county).
Replacement
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Medicines
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02/09/2014
In a letter dated September 1, 2014, the marketing authorization holder informed its customers that aflatoxin contamination had been detected in follow-up tests of dry extracts of passionflower herb processed in Pascoflair, which resulted from…