MAKLUMAT TERKINI STATUS PRODUK RANITIDINE BERKAITAN IMPURITI N-NITROSODIMETHYLAMINE (NDMA) [Kemaskini:12/2/2020]

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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

AM18A001, AM18A002, AM18A003

 

 

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:

MAKLUMAT STATUS PRODUK RANITIDINE BERKAITAN IMPURITI N-NITROSODIMETHYLAMINE (NDMA) [Kemaskini:05/12/2019]

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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