Official announcements
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Replacement
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Medicines
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06/03/2014
The distributor has informed its supplied customers in a letter dated March 5, 2014, that ten batches were identified during investigations that showed an increased risk of out-of-specification (OOS) values for the parameter "polymers, aggregates and…
Recall
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Medicines
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27/02/2014
In a letter dated February 21, 2014, the distributor informed the customers it supplied that marginal manufacturing deviations had been identified, which resulted in some NiQuitin Mini lozenges deviating in physical parameters (weight, diameter,…
Recall
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Medicines
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27/02/2014
The marketing authorization holder informed its supplied customers in a letter dated February 25, 2014, that increased customer complaints have been received regarding leaks at the emoluer connection of Clear-Flex pouches. Investigations have shown a…
Recall
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Medicines
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25/02/2014
The distributor informed its supplied customers on 03.01.2014 that during the daily control of the sterility tests of the final products of batch 02-140102 a turbidity was detected and therefore a potential contamination had to be assumed.
Replacement
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Medicines
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04/02/2014
The marketing authorization holder informed its supplied customers by letter dated February 03, 2014 that infusion bags of 0.9% NaCl 500ml Viaflo with Austrian presentation (Ch.No. 13H31E1A) were found in a carton of 0.9% NaCl 500ml Viaflo with…
Replacement
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Medicines
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03/02/2014
The marketing authorization holder informed its supplied customers in a letter dated 31.01.2014 that a quality deviation with regard to product- and process-related impurities was found in stability tests for certain batches.
Replacement
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Medicines
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23/01/2014
The marketing authorization holder informed its supplied customers in a letter dated 23.01.2014 that the batches listed show deviations in dissolution. The release of the active ingredient amitriptyline after four hours is slightly higher than…
Replacement
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Medicines
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30/12/2013
The marketing authorization holder informed its supplied customers in a letter dated December 23, 2013, that it cannot be ruled out that a frequent occurrence of hypersensitivity reactions may occur with this batch and that a precautionary withdrawal…
Recall
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Medicines
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19/12/2013
In a letter dated December 19, 2013, the marketing authorization holder informed its customers that an elevated level of a known degradation product of the active ingredient azithromycin has been detected in some vials and that a voluntary recall is…
Replacement
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Medicines
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17/12/2013
WABOSAN Arzneimittelvertriebs GmbH has informed its supplied customers by letter dated 12.12.2013 that yellow-orange precipitations have been observed in batch Y260 in individual cases and therefore a precautionary recall is being carried out. This…