Valsartan and Valsartan/HCT from Sandoz GmbH

Recall | Medicines | 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
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 recall1
BASG reference number INS-640.001-2576
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