Valsartan and Valsartan-HCT from +pharma arzneimittel gmbh
Recall
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Medicines
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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 |
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| 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 recall | 1 |
| BASG reference number | INS-640.001-2578 |
Further inquiry note
Page last modified:
12/07/2022