Official announcements
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Recall
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Medicines
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05/12/2014
The marketing authorization holder informed its customers supplied with the product in a letter dated December 2, 2014, that all batches marketed had been reviewed because deviations had been identified in stability tests. For Austria, these tests…
Recall
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Medicines
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24/11/2014
The distributor has informed its supplied customers in a letter dated 19.11.2014 that there is a possibility of crystallization (particle formation) in the injection solution of the above batch. The crystals observed are probably precipitated…
Recall
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Medicines
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21/10/2014
The marketing authorization holder informed its supplied customers in a letter dated October 21, 2014, that the affected finished product lot 4E915 was produced with an aciclovir active ingredient lot that does not meet the specifications regarding…
Recall
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Medicines
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15/10/2014
The distribution company informed its customers in a letter dated October 13, 2014, that after 3 years of storage at 30°C and 75% humidity and after 6 months of storage at 40°C and 75% humidity, increased levels of known and unknown impurities as…
Recall
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Medicines
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13/10/2014
In a letter dated October 8, 2014, the distribution company informed its supplied customers that there is a possibility of crystals forming if the enclosed diluent of batch AHZW/1 is stored at 2 to 8°C. The diluent was used for the production of this…
Recall
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Medicines
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08/10/2014
Gedeon Richter Austria GmbH" informed its supplied wholesalers and gynecologists in a letter dated 03.10.2014 that instabilities of the active ingredient Desogestrel were detected during periodic stability measurements, which could shorten the shelf…
Recall
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Medicines
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07/10/2014
The marketing authorization holder informed its supplied customers in a letter dated October 3, 2014, that the long-term stability of the two affected batches cannot be ensured and that a precautionary recall is therefore being carried out.
Safety warnings
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Medicines
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17/09/2014
In addition to isolated cases of tampered Italian Herceptin distributed in parallel, tampered MabThera of Romanian origin has now emerged.
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…