The marketing authorization holder has informed its supplied customers in a letter dated November 16, 2018, that isolated impurities or contamination of the film-coated tablets have been detected, which occurred during the packaging of the…

The marketing authorization holder has informed its supplied customers by letter dated Nov. 12, 2018, that due to a slightly increased exceedance of the specification for known impurities, the above batch is being recalled.

No acute danger, recall purely as a precautionary measure

The marketing authorization holder informed the supplied customers via its distribution partner in a letter dated 01.10.2018 that the urology catheters of the company ConvaTec may exhibit unsterility. In tests conducted with the packaging of the…

The parallel distributor - "HAEMATO PHARM GmbH" - informed its supplied customers in a letter dated October 8, 2018, that for the two batches of "Jakavi 15 mg tablets" with the batch numbers SM018 and SAD42, packages were delivered in parallel trade…

The marketing authorization holder informed its supplied customers in a letter dated August 16, 2018, that due to quality problems with one batch of ampoules, batch D1K13 is being recalled as a precautionary measure.

The marketing authorization holder informed its supplied customers in a letter dated July 5, 2018, that a production-related impurity occurred at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine…

Preliminary risk assessment of NDMA for patients

The marketing authorization holder informed its supplied customers in a letter dated 06.07.2018 that a production-related contamination of the active ingredient was detected. The substance in question is N-nitrosodimethylamine (NDMA). Therefore, a…

In a letter dated July 6, 2018, the marketing authorization holder informed its customers that a production-related contamination of the active ingredient has been detected. Therefore, a precautionary recall of all batches of "Valsartan Sandoz…