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 Film-Coated Tablets" of the strengths 80mg, 160 mg and 320mg as well as "Valsartan/HCT Sandoz Film-Coated…

No acute danger. Discontinuation of medication not recommended

The marketing authorization holder has informed its supplied customers in a letter dated July 4, 2018, that the active ingredient valsartan may contain a genotoxic impurity with carcinogenic potential.Based on this information from the active ingredient manufacturer, a recall of all batches of "Valsartan Genericon Film-Coated Tablets" in strengths…

The marketing authorization holder has informed its supplied customers in a letter dated 04.07.2018 that the active ingredient Valsartan may contain a genotoxic impurity with carcinogenic potential. Based on this information from the active ingredient manufacturer, a recall of all batches of "Valsartan +pharma Film-Coated Tablets" in the strengths…

The marketing authorization holder has informed its supplied customers in a letter dated 05.07.2018 that an impurity was detected during the review at the active ingredient level. This impurity is classified as potentially carcinogenic. Therefore, a recall of "Valsartan STADA Film Tablets" in the strengths 80 mg, 160 mg, 320 mg and "Valsartan HCT…

In a letter dated July 5, 2018, the marketing authorization holder informed its customers that the active ingredient manufacturer had detected the production-related impurity N-nitrosodimethylamine (NDMA) in the active ingredient valsartan. Therefore, the above mentioned batches of "Valsartan Actavis Film-Coated Tablets" in the strengths 40mg,…

The marketing authorization holder has informed its customers in a letter dated December 31, 2009, that a production-related impurity has arisen at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine (NDMA), which is classified as a potential carcinogen. Therefore, a recall of "Valsartan G.L.…

The marketing authorization holder informed its supplied customers in a letter dated December 31, 2009, that a production-related impurity occurred during a synthesis step at the active ingredient manufacturer's. The impurity is N-nitrosodimethylamine (NDMA). This impurity is N-nitrosodimethylamine (NDMA), which is classified as a potential…

The marketing authorization holder has informed its supplied customers in a letter dated 11.06.2018 that visible particles were found in part of a production batch during quality control. For this reason, the above batch is being recalled as a precautionary measure.

The marketing authorization holder has informed its supplied customers in a letter dated May 25, 2018, that a blister strip of another product from the same active ingredient group has been discovered in batch W28311 in a single package. As a precautionary measure, the affected batch is therefore being recalled due to this possible submixture.