The marketing authorization holder has informed its supplied customers in a letter dated July 25, 2017, that a test result within the scope of a stability study showed a reduced active ingredient content. Therefore, the batch 559CG placed on the market in Austria, which is related to this stability study, is recalled from the market.

The marketing authorization holder has informed its supplied customers in a letter dated July 04, 2017, that individual bottles filled with distilled water were included in the packaging of Buerlecithin liquid 500 ml. For this reason, this batch is recalled. There is no risk to patient safety.

The marketing authorization holder has informed its supplied customers in a letter dated June 21, 2017, that in the course of stability tests a trend towards a decrease of the active ingredient "Ambroxol hydrochloride" towards the end of the term has been detected. Therefore, three batches with batch numbers 2015008, 2016002, 2016019, which are…

The marketing authorization holder has informed its supplied customers in a letter dated 23.06.2017 that due to the global decision of the company, the marketing authorization of the medicinal product "Trobalt" will be withdrawn in all strengths. Therefore, a recall will be carried out at wholesalers and pharmacies from 01.07.2017.

The marketing authorization holder has informed its supplied customers in a letter dated May 23, 2017, that increased black visible particles have been detected in a batch of "Elotrace - Infusion Additive".Based on these observations, the affected batch 16LC6994 is being recalled.

The marketing authorization holder has informed its supplied customers in a letter dated April 27, 2017, that the affected batches are being recalled due to a possible minor contamination with ethylene glycol. According to current knowledge, the occurrence of side effects due to the contamination for patients is unlikely.

Meda Pharma GmbH expands recall of EpiPen auto-injectors to include additional lots

The marketing authorization holder has informed its supplied customers about the extended voluntary recall of additional EpiPen batches in a letter dated April 12, 2017. There is a very low probability that the auto-injector does not work correctly. Worldwide, there were two customer complaints outside of Austria where the pen failed to trigger…

The marketing authorization holder has informed its supplied customers in a letter dated April 6, 2017, that individual bottles filled with 100 ml of distilled water were included in the packaging of Buerlecithin liquid 1000 ml. For this reason, this batch is recalled. There is no risk to patient safety

Worldwide, there were two complaints outside of Austria that the auto-injector did not work correctly. Meda Pharma GmbH is therefore recalling a batch of EpiPen 300 micrograms in Austria.