Official announcements
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Recall
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Medicines
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20/01/2015
The distributor informed its supplied customers that during the daily sterility test control of the final products of batch 02-150115 a turbidity was detected and therefore a potential contamination had to be assumed.
Recall
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Medicines
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15/01/2015
The distributor informed its supplied customers that during the daily sterility test control of the final products of batch 02-150112 a turbidity was detected and therefore a potential contamination had to be assumed.
Recall
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Medicines
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13/01/2015
The marketing authorization holder informed its supplied customers in a letter dated January 13, 2015, that the package leaflet in Greek was enclosed with individual packages of batch 42053 and that a precautionary recall is therefore being carried…
Recall
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Medicines
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17/12/2014
The distribution company has informed its supplied customers in a letter dated December 16, 2014, that in individual cases a dosage inaccuracy (slight underdosage) has been detected in dosing pumps in the prepackages of Axura 5 mg/pump stroke, 50 ml…
Recall
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Medicines
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17/12/2014
The distribution company has informed its supplied customers in a letter dated December 16, 2014, that in individual cases a dosage inaccuracy (slight underdosing) has been detected in dosing pumps in the prepackages of Ebixa5 mg/pump hub, 50 ml…
Recall
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Medicines
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05/12/2014
The marketing authorization holder informed its customers supplied with the product in a letter dated December 2, 2014, that all batches marketed had been reviewed because deviations had been identified in stability tests. For Austria, these tests…
Recall
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Medicines
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24/11/2014
The distributor has informed its supplied customers in a letter dated 19.11.2014 that there is a possibility of crystallization (particle formation) in the injection solution of the above batch. The crystals observed are probably precipitated…
Recall
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Medicines
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21/10/2014
The marketing authorization holder informed its supplied customers in a letter dated October 21, 2014, that the affected finished product lot 4E915 was produced with an aciclovir active ingredient lot that does not meet the specifications regarding…
Recall
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Medicines
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15/10/2014
The distribution company informed its customers in a letter dated October 13, 2014, that after 3 years of storage at 30°C and 75% humidity and after 6 months of storage at 40°C and 75% humidity, increased levels of known and unknown impurities as…
Recall
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Medicines
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13/10/2014
In a letter dated October 8, 2014, the distribution company informed its supplied customers that there is a possibility of crystals forming if the enclosed diluent of batch AHZW/1 is stored at 2 to 8°C. The diluent was used for the production of this…