Official announcements
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Recall
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Medicines
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14/10/2013
The marketing authorization holder has informed its supplied customers in a letter dated 11.10.2013 that complaints have arisen describing the disintegration of the pen after repeated use. Since the pen can no longer be used after this, a…
Recall
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Medicines
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09/10/2013
On October 8, 2013, the marketing authorization holder informed its customers that injection vials may have an externally invisible defect under the crimp cap due to the capping machine and that product leakage may occur when the vial is shaken.…
Replacement
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Medicines
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02/10/2013
During a routine quality check, a small number of prefilled syringes were found to contain particles consisting mainly of cellulose fibers. The voluntary exchange only affects investigational products with the above batch numbers that were marketed…
Recall
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Medicines
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17/09/2013
The marketing authorization holder has informed its supplied customers in a letter dated 13.09.2013 that investigations have shown that the optimal efficacy of batch 15159721 cannot be guaranteed over the entire shelf life and therefore a…
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…