Valsartan and Valsartan/HCT from Sandoz GmbH
Recall
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Medicines
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06/07/2018
In a letter dated July 6, 2018, the marketing authorization holder informed its customers that a production-related contamination of the active ingredient has been detected. Therefore, a precautionary recall of all batches of "Valsartan Sandoz Film-Coated Tablets" of the strengths 80mg, 160 mg and 320mg as well as "Valsartan/HCT Sandoz Film-Coated Tablets" in the strengths 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25mg, 320 mg/12.5 mg and 320mg/25 mg is being carried out.
| Name of the medicinal product | 1. Valsartan Sandoz 80 mg – Filmtabletten 2. Valsartan Sandoz 160 mg – Filmtabletten 3. Valsartan Sandoz 320 mg – Filmtabletten 4. Valsartan/HCT Sandoz 80 mg/12,5 mg – Filmtabletten 5. Valsartan/HCT Sandoz 160 mg/12,5 mg – Filmtabletten 6. Valsartan/HCT Sandoz 160 mg/25 mg – Filmtabletten 7. Valsartan/HCT Sandoz 320 mg/12,5 mg –Filmtabletten 8. Valsartan/HCT Sandoz 320 mg/25 mg – Filmtabletten |
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| Marketing authorisation number(s) | 1. 1-29521 2. 1-29522 3. 1-29525 4. 1-29536 5. 1-29537 6. 1-29538 7. 1-29539 8. 1-29540 |
| Marketing authorisation holder | Sandoz GmbH |
| Batch number(s) | Alle in der Laufzeit befindlichen Chargen, nämlich: 1. FY0724, GC2270, GL0019, GT8308, HE5042, HK6314 2. FY4285, GF7226, GF7227, GN5277, GV7106, HC4405, HC4406, HK1606, HP1755, HW3569, HX1784 3. FU7037, GB1179, GM2204, GS7045, GS7046, HD4384, HN8869, HR7299, HW3942 4. FW0323, GF4539AA, GM3629, GY4178, HD4496, HM9099, HT3701, HV8308 5. FV4650, FV4651, GA7177, GA7178, GF7230, GS5587, HD4374, HD4375, HP4739, HU4657, HV3544 6. FR6579, FW6892, GG0915, GN9236, GN9237, GY9695, HJ7757, HV2590, HW8621 7. FS7534, FZ0871, GN9297, GY2793, HD6194, HX3936 8. FZ0872, GN1123, GX2498, HJ2519, HX5680, HY2334 |
| Classification of the recall | 1 |
| BASG reference number | INS-640.001-2576 |
Further inquiry note
Page last modified:
12/07/2022