The marketing authorization holder informed its supplied customers in a letter dated March 20, 2014, that isolated blisters of Calmolan 0.18 mg (packs of 30 / 3 blisters) may have been incorrectly packaged and labeled with an outer label of Calmolan…

The marketing authorization holder informed its supplied customers in a letter dated 19.03.2014 that underfilling of the15 ml package size had been detected. This is not a case of underfilling during production, but of evaporation of the alcohol due…

"Janssen-Cilag Pharma GmbH" informed its supplied customers in a letter dated March 13, 2014, that due to continuous assessment of the product portfolio and return of the license to Shionogi & Co, Ltd, the Group has decided to recall "Doribax 500 mg…

Madaus Ges.m.b.H." has informed its supplied customers by letter dated 11.03.2014 that within the framework of ongoing stability tests, quality deviations have been detected which represent a microbiological contamination and therefore a recall will…

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…

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,…

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…

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.

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…

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.