Official announcements
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Medicines
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25/04/2016
The marketing authorization holder has informed its supplied customers by letter dated April 20, 2016, that an internal quality control has detected an undercutting of the phenol content and therefore the affected batches of the Prick Test Solution…
Recall
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Medicines
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21/04/2016
The marketing authorization holder informed its supplied customers in a letter dated 19.04.2016 that an error in the filling process was detected at the manufacturer. The error results in a few vials possibly containing a too high concentration. The…
Recall
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Medicines
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21/04/2016
The marketing authorization holder has informed its supplied customers in a letter dated 20.04.2016 that the marketing authorizations of medicinal products containing fusafungin (Locabiosol / Bioparox / Locabiotal / Fusaloyos as oral spray, nasal…
Recall
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Medicines
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18/04/2016
The marketing authorization holder has informed its supplied customers in a letter dated April 15, 2016, that a possible non-sterility cannot be excluded and therefore a precautionary recall is being carried out. This recall results from an…
Recall
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Medicines
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14/04/2016
In a letter dated April 13, 2016, the marketing authorization holder informed its customers that the above-mentioned batch of "Curatoderm - Ointment" was found to be mixed with "Amciderm - Cream" and is therefore being recalled. "Amciderm - Creme" is…
Recall
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Medicines
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01/04/2016
The pharmaceutical company "Amomed Pharma GmbH" has informed its supplied customers by letter dated 11.03.2016 that in the course of stability testing a clear brown coloration of the solution was detected in some ampoules. This brown coloration…
Recall
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Medicines
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24/02/2016
Agepha Pharma has informed its customers in a letter dated 24.02.2016 about the recall of the mentioned batch for the following reason: The composition of the eye drops has been changed (addition of povidone), but the official assessment of this…
Recall
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Medicines
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28/01/2016
The company B. Braun Austria Ges.m.b.H. informed its supplied customers in a letter dated 28.01.2016 that due to customer complaints about leaking Ecoflac® plus infusion containers of the mentioned batch a precautionary recall due to possible leakage…
Recall
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Medicines
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18/12/2015
The marketing authorization holder informed its supplied customers in a letter dated December 16, 2015, that a reduced active ingredient content was detected in the above batch in the course of routine stability tests, so that the shelf life until…
Recall
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Medicines
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17/12/2015
The marketing authorization holder and its distribution partner informed the supplied customers in a letter dated 14.12.2015 that after the introduction of a new IT system in the production facility "Stallergenes S.A." in Antony, France, difficulties…