Official announcements
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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…
Replacement
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Medicines
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03/07/2014
The marketing authorization holder informed its supplied customers by letter dated July 1, 2014, that the sedacoron batch DV6862 delivered in the period from February 2014 to May 2014 exhibited increased crystallization, so that a precautionary…
Recall
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Medicines
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18/06/2014
The marketing authorization holder informed its supplied customers in a letter dated 17.06.2014 that aflatoxin contamination resulting from contamination of individual batches of passionflower herb was detected due to subsequent, unscheduled special…
Recall
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Medicines
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17/06/2014
The marketing authorization holder informed its supplied customers in a letter dated June 16, 2014, that the manufacturer cannot rule out the possibility that the solution in individual bottles is contaminated with small black particles, so that a…
Safety warnings
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Medicines
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04/06/2014
Update on stolen vials of Herceptin and other products, newly affected: Avastin and MabThera
Recall
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Medicines
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04/06/2014
The parallel distributor informed its supplied customers on 03.06.2014 and asked for a stock check of the affected batches.
Recall
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Medicines
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04/06/2014
The parallel distributor informed its supplied customers on 03.06.2014 and asked for a stock check of the affected batches.
Recall
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Medicines
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04/06/2014
The parallel distributor informed its supplied customers on 04.06.2014 and asked for a stock check of the affected batches.