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 recall | 1 |
| BASG reference number | INS-640.001-2578 |
Further inquiry note
Page last modified:
12/07/2022