Valsartan and Valsarcomp from Genericon Pharma GmbH

Recall | Medicines | 05/07/2018

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 80 mg, 160 mg and 320 mg as well as "Valsarcomp Film-Coated Tablets" in strengths 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg and 320 mg/25 mg on the market is being implemented.

Name of the medicinal product 1. Valsartan Genericon 80 mg Filmtabletten
2. Valsartan Genericon 160 mg Filmtabletten
3. Valsartan Genericon 320 mg Filmtabletten
4. Valsarcomp 80 mg/12,5 mg Filmtabletten
5. Valsarcomp 160 mg/12,5 mg Filmtabletten
6. Valsarcomp 160 mg/25 mg Filmtabletten
7. Valsarcomp 320 mg/25 mg Filmtabletten
Marketing authorisation number(s) 1. 1-29606
2. 1-29607
3. 1-29608
4. 1-30691
5. 1-30692
6. 1-30693
7. 1-30695
Marketing authorisation holder Genericon Pharma GmbH
Batch number(s) Alle in der Laufzeit befindlichen Chargen
Classification of the recall1
BASG reference number INS-640.001-2578
Email

Further inquiry note