Official announcements
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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.
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.
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…
Recall
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Medicines
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19/08/2014
The parallel distributor informed its supplied customers on 13.08.2014 and asked for a stock check of the affected batches, as these batches were illegally distributed from Italy and entered the legal distribution chain.
Recall
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Medicines
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07/08/2014
The manufacturer informed its supplied customers by letter dated July 24, 2014, that the active ingredient manufacturer "SIMS Società Italiana Medicinali Scandicci srl" was assessed by the responsible inspection authority as not GMP-compliant and…
Recall
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Medicines
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17/07/2014
The marketing authorization holder informed its supplied customers by letter dated July 15, 2014, that a loss of sterility for the Absorbable Collagen Sponge (ACS) was detected during a stability study after 24 months, so that a recall is being…
Replacement
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Medicines
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08/07/2014
The marketing authorization holder has informed wholesalers and pharmacies in a letter dated 07.07.2014 that the duration of the above batches was printed incorrectly and therefore a replacement will be made. The runtime indicated on the labeling is…