1. Berdasarkan penilaian dan ujian makmal oleh Kementerian Kesihatan Malaysia (KKM) dan syarikat pemegang pendaftaran produk ke atas produk-produk ranitidine yang berdaftar, didapati tiga (3) produk tidak melebihi had NDMA yang dibenarkan dan tujuh belas (17) produk telah dipanggil balik kerana melebihi had impuriti NDMA yang dibenarkan seperti yang disenaraikan dalam Jadual 1 dan 2.
Jadual 1: Produk yang tidak terlibat dalam panggil balik
|
Bil |
Nama Produk |
No Pendaftaran |
|
1 |
Arnetin 25mg/ml Injection |
MAL20033329AZ |
|
2 |
Vesyca Injection 25mg/ml |
MAL08021472AZ |
|
3 |
Rantac Injection 50mg/2ml |
MAL19991695AZ |
Jadual 2: Senarai produk ranitidine berdaftar yang dipanggil balik
|
Bil |
Nama Produk |
No Pendaftaran |
Kelompok yang di panggil balik |
|
1 |
Zantac Injection 50mg/2ml |
MAL19950591ARZ |
6N9B, XM6E, 928T, VM7P-C, 5Y2U, VM7P-B, H35J, P86N-A, P86N, C78T-A |
|
2 |
Zantac Syrup 150mg/10ml |
MAL19910829ACRZ |
18K001, 17M003 |
|
3 |
Hyzan Tablet 150mg |
MAL19984063AZ |
345801, 354111, 357672, 360621, 366701, 376271, 384771 |
|
4 |
Vesyca Film Coated Tablet 150mg |
MAL19991131AZ |
BK004, BK005, CB001, CD002, CL007, DB002 |
|
5 |
Apo-Ranitidine 300mg tablet |
MAL19988448AZ |
PJ9367 |
|
6 |
Apo-Ranitidine 150mg tablet |
MAL19986966AZ |
NJ9249, NM3455, NP5652, NV9197, NV9198, PY3829, RF0019 |
|
7 |
Ranitic Tablet 150mg |
MAL19988460AZ |
JC4082, JC4085, FM3161, FM3163 |
|
8 |
Pharmaniaga Ranitidine Tablet 150 Mg |
MAL19987368AZ |
Semua Kelompok |
|
9 |
Pharmaniaga Ranitidine Tablet 300 Mg |
MAL19987370AZ |
Semua Kelompok |
|
10 |
Histac Tablet 150mg |
MAL19972524AZ |
19050497, 19050498, 19060622, 19060623, 19070738, 19070739, 19080818, 19040374, 19040375, 19030237, 3970827, 2850576 |
|
11 |
Rantac Tablet 150mg |
MAL19991696AZ |
PR47001, PR47020, PR47031, PR48010, PR48011, PR48021, PR49004, PR49026, PR49027 |
|
12 |
Rantac Tablet 300mg |
MAL20051293AZ |
PR87001, PR87002, PR87003, PR88001, PR88002, PR89001 |
|
13 |
X`Tac Tablet 150mg |
MAL19972537AZ |
1804283, 1805295, 1808339, 1902173 |
|
14 |
Biolab Ranitidine 150mg Tablet |
MAL20034188AZ |
T178446, T17C714, T181011, T181042, T191104, T193198, T195391
|
|
15 |
Biolab Ranitidine 300mg Tablet |
MAL20034189AZ |
T178401, T184300, T191043, T193192 |
|
16 |
Gastril 50mg/2ml Injection |
MAL19972531AZ |
180785L,182383L,190391L,190986L, 191773L,191522L, 192011, 192363L |
|
17 |
Ameket Injection 2ml |
MAL20013772AZ |
AM17C001, AM17C002, AM17C003, AM17C004, AM17F005, AM17F006, AM17F007, AM17J008, AM17J009, AM17J010, AM17J011, AM17K012, AM17K013, AM17L014, AM18A001, AM18A002, AM18A003, AM18A004 |
Nota: Zantac Tablet 150mg (MAL19871471ARZ) yang dipanggil balik oleh Health Sciences Authority (HSA), Singapura tidak dipasarkan di Malaysia.
2. Maklumat lanjut berkenaan kenyataan akhbar dan soalan-soalan lazim (FAQ) boleh dicapai melalui link di bawah:
