Official announcements
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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…
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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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.
