Official announcements
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Recall
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Medicines
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10/02/2015
The marketing authorization holder informed its supplied customers in a letter dated February 9, 2015, that the specified batches were being recalled because deviations from the specified dissolution value had been detected in the samples returned.
Recall
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Medicines
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06/02/2015
The marketing authorization holder has informed its supplied customers that due to Commission Implementing Decision C(2014) 6030 of 19.08.2014 concerning marketing authorizations for medicinal products for human use for topical application with high…
Recall
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Medicines
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20/01/2015
The distributor informed its supplied customers that during the daily sterility test control of the final products of batch 02-150115 a turbidity was detected and therefore a potential contamination had to be assumed.
Recall
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Medicines
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15/01/2015
The distributor informed its supplied customers that during the daily sterility test control of the final products of batch 02-150112 a turbidity was detected and therefore a potential contamination had to be assumed.
Recall
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Medicines
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13/01/2015
The marketing authorization holder informed its supplied customers in a letter dated January 13, 2015, that the package leaflet in Greek was enclosed with individual packages of batch 42053 and that a precautionary recall is therefore being carried…
Recall
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Medicines
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17/12/2014
The distribution company has informed its supplied customers in a letter dated December 16, 2014, that in individual cases a dosage inaccuracy (slight underdosage) has been detected in dosing pumps in the prepackages of Axura 5 mg/pump stroke, 50 ml…
Recall
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Medicines
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17/12/2014
The distribution company has informed its supplied customers in a letter dated December 16, 2014, that in individual cases a dosage inaccuracy (slight underdosing) has been detected in dosing pumps in the prepackages of Ebixa5 mg/pump hub, 50 ml…
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…
