Official announcements
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Recall
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Medicines
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20/11/2019
Die Zulassungsinhaberin hat die belieferten Kundinnen und Kunden mit Schreiben vom 20.11.2019 informiert, dass aufgrund von eingeleiteten Untersuchungen auf europäischer Ebene eine Verunreinigung des Wirkstoffes Ranitidin mit N-Nitrosodimethylamin (NDMA) bei oben angeführten Zulassungen von Ulsal nicht ausgeschlossen werden kann.
Recall
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Medicines
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29/10/2019
The marketing authorisation holder informed its customers on October 29, 2019 that some of the three-chamber bags show deviations in pH value, colouring and emulsion quality.
Recall
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Medicines
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24/10/2019
The marketing authorisation holder informed its customers on October 24, 2019 that a review of ranitidine medicines after tests showed that below mentioned batches may contain an impurity called N-nitrosodimethylamine (NDMA).
Recall
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Medicines
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24/10/2019
The marketing authorisation holder informed its customers on October 24, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).
Recall
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Medicines
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23/10/2019
The marketing authorisation holder informed its customers on October 22, 2019 that following out-of-specification results during manufacturing below mentioned batches are recalled as a precautionary measure.
Recall
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Medicines
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26/09/2019
The marketing authorisation holder informed its customers on September 26, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).
Recall
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Medicines
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26/09/2019
The marketing authorisation holder informed its customers on September 26, 2019 that a review of ranitidine medicines after tests showed that "Zantac Brausetabletten" may contain an impurity called N-nitrosodimethylamine (NDMA).
Recall
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Medicines
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26/09/2019
The marketing authorisation holder informed its customers on September 26, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).
Safety warnings
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Medicines
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17/09/2019
Information on NDMA contamination in ranitidine medicines and recalls
Recall
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Medicines
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17/09/2019
The marketing authorisation holder informed its customers on September 16, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).