Official announcements
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Recall
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Medicines
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04/06/2013
The marketing authorization holder informed its supplied customers in a letter dated June 3, 2013, that in the course of stability tests after 24 months of storage, non-specification-compliant results were found for a batch of Cileste in the…
Recall
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Medicines
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24/05/2013
The marketing authorization holder has informed its supplied customers in a letter dated 24.05.2013 that particles were observed in some vials. For this reason, the above mentioned batches are recalled as a precautionary measure.
Recall
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Medicines
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23/05/2013
During a routine test, leaks in the area of the predetermined breaking point at the neck of an amber glass ampoule of the size 1 ml were discovered in a product batch that has not yet been released, which are due to a material defect in the glass.…
Recall
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Medicines
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18/04/2013
The marketing authorization holder informed its customers in a letter dated April 18, 2013, that due to a technical defect during production, isolated particles were observed in the prefilled syringes. In the course of a 100% inspection, prefilled…
Recall
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Medicines
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19/03/2013
The marketing authorization holder has informed its supplied customers and medical home pharmacies that a microbiological contamination has been detected in a batch of the drug "Magnesium Verla i.v./i.m. Injection Solution" from Verla-Pharm…
Recall
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Medicines
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31/01/2013
The distributor informed its supplied customers that during stability tests after a storage period of more than two years the specifications of the product could not be met. An impurity - "Desloratadine Citric Amide" - was detected. As the batches on…
Recall
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Medicines
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22/01/2013
The marketing authorization holder has informed its supplied customers that preliminary results from the HPS2-THRIVE study (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) failed to show any additional benefit of…
Replacement
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Medicines
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20/12/2012
The marketing authorization holder informed its supplied customers in a letter dated Dec. 20, 2012, that the batch would be replaced due to unusual discoloration after reconstitution.
Replacement
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Medicines
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19/12/2012
The distributor has informed its supplied customers that the above batch was intended for Germany or was placed on the market in Austria in German presentation and thus an exchange for Austrian goods will be carried out.
Recall
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Medicines
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04/12/2012
In a letter dated November 29, 2012, the marketing authorization holder informed the physicians concerned that the shelf life of the physician samples with the batch number 865356 had already expired when they were dispensed (expiration date:…