Official announcements
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Replacement
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Medicines
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22/08/2013
The marketing authorization holder informed its supplied customers in a letter dated August 22, 2013, that visible particles were detected in some vials and that a recall of the two affected batches will therefore be carried out.
Recall
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Medicines
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06/08/2013
B. Braun Austria Ges.m.b.H. has informed its supplied customers in a letter dated August 5, 2013, that a customer complaint has informed the marketing authorization holder about a leaking Ecoflac plus infusion container in batch 13103411. Since it…
Recall
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Medicines
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11/07/2013
The marketing authorization holder informed its supplied customers in a letter dated July 9, 2013, that in the course of quality assurance measures it was determined that in batch 1200758 isolated ampoules with yellowish discolored contents and thus…
Replacement
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Medicines
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04/07/2013
The distribution partner "sanofi-aventis GmbH" informed its supplied customers in a letter dated 04.07.2013 that the retained samples of the above batch showed deviations. After a storage time of 26 months, aggregates above the permissible limit of…
Recall
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Medicines
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20/06/2013
The marketing authorization holder has informed its supplied customers in a letter dated June 19, 2013, that due to a manufacturing problem and the associated risk of microbial contamination with "Sphingomonas yanoikuyae", the above mentioned batches…
Replacement
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Medicines
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19/06/2013
The marketing authorization holder informed its supplied customers in a letter dated June 18, 2013, that due to an individual complaint from the German market regarding a plastic ampoule leaking at the neck of the bottle, batch 12FHL21 will be…
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…