Valsartan and Valsartan HCT from STADA 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 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 STADA Film Tablets" in the strengths 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg will be carried out exclusivelyfor the above mentioned batches.
| Name of the medicinal product | 1. Valsartan STADA 80 mg Filmtabletten 2. Valsartan STADA 160 mg Filmtabletten 3. Valsartan STADA 320 mg Filmtabletten 4. Valsartan HCT STADA 160 mg/12,5 mg Filmtabletten 5. Valsartan HCT STADA 160 mg/25 mg Filmtabletten 6. Valsartan HCT STADA 320 mg/12,5 mg Filmtabletten 7. Valsartan HCT STADA 320 mg/25 mg Filmtabletten |
|---|---|
| Marketing authorisation number(s) | 1. 1-28990 2. 1-28991 3. 1-28992 4. 1-29451 5. 1-29454 6. 1-29452 7. 1-29455 |
| Marketing authorisation holder | STADA Arzneimittel GmbH |
| Batch number(s) | 1. 70488, 73213 2. 64010V, 73338 3. 72872 4. 64003V, 70414 5. 70584, 74195 6. 70716 7. 65237 |
| Classification of the recall | 1 |
| BASG reference number | INS - 640.001 - 2580 |
Further inquiry note
Page last modified:
12/07/2022