Human medicines
Chloramphenicol micronised
Recall
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Medicines
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06/12/2019
The manufacturer informed its customers on 03 December, 2019, that the listed batches of active pharmaceutical ingredients are recalled as a precautionary measure due to the withdrawal of the manufacturer's certificate of the Indian original manufacturer "Mehta API Pvt. Ltd.".
Chloramphenicol micronised
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Ulsal Brausetabletten, Filmtabletten, Ampullen
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.
Ulsal Brausetabletten, Filmtabletten, Ampullen
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Nutriflex Omega Emulsion zur Infusion
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.
Nutriflex Omega Emulsion zur Infusion
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Ulsal lösliche Tabletten
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).
Ulsal lösliche Tabletten
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Ranitidin STADA
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).
Ranitidin STADA
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Avonex
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.
Avonex
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Ranitidin Accord
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).
Ranitidin Accord
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Zantac Brausetabletten
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).
Zantac Brausetabletten
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Ranitidin ratiopharm
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).
Ranitidin ratiopharm
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Review ranitidine medicines following detection of NDMA
Safety warnings
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Medicines
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17/09/2019
Information on NDMA contamination in ranitidine medicines and recalls
Review ranitidine medicines following detection of NDMA
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