Due to a manufacturing problem during the filling of the cartridges, individual products of the above mentioned batches of "NovoMix® 30 FLexPen®" may have an insulin content that is too high or too low. According to information from the Danish marketing authorization holder, NovoNordisk A/S, the insulin concentration may deviate in a small number…

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 precautionary recall is being carried out.

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. Since sterility cannot be guaranteed, this batch is being recalled. This medicinal product is authorized…

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 for two clinical trials (Amgen Protocol Nos. 20050209 and 20060289). Amgen has identified those…

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 precautionary recall of the affected batch is being carried out. All other batches of Dancor available in…

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.

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 cannot be ruled out that other infusion containers of the above batch are affected by a possible leak,…

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 a possible reduced active ingredient content were observed. Other batches of this product are not…

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 5% were detected. As the batch is still within the period of 36 months, a recall was carried out.

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 042265AD, 042285AD, 042304AD1 are being recalled as a precautionary measure. The information letter…