Recall of certain lots of "Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" containing valsartan active ingredient manufactured by "Mylan Laboratory Limited".

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 film-coated tablets into the blisters. The batch AV069 is therefore recalled as a precautionary measure.

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 catheters, the possibility of breaking the sterile barrier was detected. Thus, the catheters 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 in Austria, which "Novartis Europharm Limited" as the marketing authorization holder has not…

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 (NDMA), which is classified as a potential carcinogen. Therefore, the affected batches were…

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 precautionary recall of all batches of "Valsartan 1A Pharma Film-Coated Tablets" of the strengths 80mg…