Ranigast
The presence of N-nitrosodimethylamine (NDMA) contamination was found in the active substance ranitidine used to manufacture the Ranigast 150 mg, film-coated tablet batches, which constitutes a quality defect of the medicinal product. Potential effects: increased risk of carcinogenic effects and toxic liver damage.
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Risk Level
Critical
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Batch Number
41116, 21116, 31116, 71116, 81116, 51116, 61116, 90117, 30117, 130117, 120117, 110117, 80117, 70117, 100117, 80317, 60517, 50317, 40317, 30317, 100347, 70317, 120317, 110317, 90317, 50417, 60417, 80417, 90417, 70417, 10717, 70717, 30717, 20717, 40717, 50717, 60717, 80717, 70917, 30917, 40917, 60917, 50917, 171017, 121017, 111017, 81017, 131017, 161017, 151017, 141017, 181017, 191017, 101017, 41117, 61117, 51117, 21117, 71217, 11217, 31217, 21217, 41217, 51217, 61217, 111217, 101217, 60218, 90218, 30218, 20218, 10218, 50218, 70218, 80218, 40218, 10418, 20418, 40418, 30418, 40618, 30618, 20618, 70818, 80818, 10818, 40818, 20818, 50818, 60818, 40918, 20918, 30918, 11018, 21016, 31018, 101018, 111018, 31118, 21118, 41118, 11118, 81118, 71118, 61118, 11218, 21218, 31218, 40119, 100119, 50119, 60119, 80119, 70119, 70219, 60219, 20319, 10319, 30319, 10419, 40519, 30519, 10519, 50519, 30619, 20519, 10619, 20619, 50819, 60819
Recall Date
28.10.2019
Category
Medicines & supplements