DFTAR OBAT-OBAT YANG TIDAK MEMENUHI SYARAT MUTU / DITARIK DARI PEREDARAN TAHUN 2017
no
|
nama obat
|
bahan aktif
|
pabrik
|
No.registrasi
|
no.batch
|
ED
|
No.Surat
|
Keterangan
|
1
|
Ambroxol sirup Botol 60 ml
|
Tiap 5 ml Mengandung ambroxol 15 mg
|
PT. Novapharin
|
GKL1134009137A1
|
1602-09-184, 1502-07-184, 1606-19-184A
|
Feb 19
Feb 19
Jun 19
|
B-PW.02.03.332.3.12.16.9706
|
TMS pH
|
2
|
Asam Mefenamat Kaplet
|
Asam mefenamat 500 mg
|
PT. Bernofarm
|
DKL8802313409A1
|
TSC20744
TSK72743
TSC21944
TSK71843
TSL86843
TSE57444
|
Feb 20
Sept 19
Feb 20
Sept 19
Okt 19
Mei 20
|
B-PW.02.03.332.3.12.16.10031
|
TMS Uji Disolusi
|
3
|
Asam Mefenamat Kaplet
|
Asam mefenamat 500 mg
|
PT. Novapharin
|
GKL0734007609A1
|
1601-51-120
|
Jan 20
|
B-PW.02.03.332.3.12.16.9975
|
TMS Uji Disolusi
|
4
|
Bisoprolol Tablet
|
Bisoprolol Hemifumarat 5 mg
|
PT.Novell Pharmaceutical lab
|
GKL0633516517A1
|
E8F009
|
Jun 17
|
B-PW.02.03.332.3.12.16.9945
|
TMS Uji Keseragaman Kandungan
|
5
|
Carbazochrome Sod.Sulfonate I.V Inj 50 mg/10 ml
|
Carbazochrome sod sulfonate I.V
|
PT.novell Pharmaceutical lab Untuk PT Etercon Pharma
|
GKL1315713143A1
|
16D164
17D249
17C089
17B182
17F209
16D162
16D163
16E152
|
-
|
B-PW.02.03.332.3.12.16.9707
B-PW.02.03.332.3.12.16.9708
|
TMS Pemerian (perubahan Warna)
|
6
|
Farmoten 12,5 Tablet
|
Captopril 12,5 mg
|
PT. Pratapa Nirmala
|
DKL9131501810B1
|
-
|
-
|
B-PW.02.03.332.3.12.16.9561
|
No.Req Telah kadaluarga sejak 14 April 2014 (obat Tanpa izin
Edar)
|
7
|
Fenpro Suspensi Botol 60 ml
|
Tiap 5 ml Mengandung Ibuprofen 100 mg
|
PT. Rama Emerald Multi sukses
|
DTL1428911933A1
|
S4066AE
|
Des 18
|
B-PW.02.03.332.3.12.16.9709
|
TMS Kadar
|
8
|
Furosemid Tablet
|
furosemid 40 mg
|
PT. Sampharindo
|
GKL0423407010A1
|
DG0801
|
Jul 19
|
B-PW.02.03.332.3.12.16.9976
|
TMS Disolusi
|
9
|
Ibuprofen Suspensi Botol 60 ml
|
tiap 5 ml mengandung ibubrofen 100 mg
|
PT. Rama Emerald Multi sukses
|
GTL1528912433A1
|
S2040AF
|
Mei 19
|
B-PW.02.03.332.3.12.16.9709
|
TMS Kadar
|
10
|
Glyceryl Guaiacolate Tablet (botol 1000 tablet)
|
guafenesin 100mg /tablet
|
PT. Ciubros Farma
|
GBL9504000510A1
|
AO05T14B
|
Jan19
|
B-PW.02.03.332.3.12.17.00142
|
TMS Uji disolusi
|
11
|
Glyceryl Guaiacolate Tablet (botol 1000 tablet)
|
guafenesin 100mg /tablet
|
PT. Ciubros Farma
|
GBL9504000510A1
|
IO09T14B
|
Sept 19
|
B-PW.02.03.332.3.12.17.00142
|
TMS uji disolusi
|
12
|
Ciprofloxacin Tab 500 mg
|
ciprofloxacin 500 mg/ tablet
|
PT. Bernofarm
|
GKL0202332317A1
|
-
|
-
|
B-PW.02.03.332.3.12.17.0633
|
NIE GKL0202332317A1 telah habis masa berlaku pada tgl 29 Nov
2015
|
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