Valsartan and Valsartan-HCT from +pharma arzneimittel gmbh

Recall | Medicines | 05/07/2018

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 80 mg, 160 mg and 320 mg as well as "Valsartan-HCT +pharma Film-Coated Tablets" in the strengths 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg on the market is being carried out.

Name of the medicinal product 1. Valsartan +pharma 80 mg Filmtabletten
2. Valsartan +pharma 160 mg Filmtabletten
3. Valsartan +pharma 320 mg Filmtabletten
4. Valsartan-HCT +pharma 80 mg/12,5 mg Filmtabletten
5. Valsartan-HCT +pharma 160 mg/12,5 mg Filmtabletten
6. Valsartan-HCT +pharma 160 mg/25 mg Filmtabletten
Marketing authorisation number(s) 1. 1-30677
2. 1-30678
3. 1-30679
4. 1-31509
5. 1-31510
6. 1-31511
Marketing authorisation holder +pharma arzneimittel gmbh
Batch number(s) Alle in der Laufzeit befindlichen Chargen
Classification of the recall1
BASG reference number INS-640.001-2578

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