LAMPIRAN OBAT YANG TIDAK MEMENUHI SYARAT MUTU / DITARIK DARI PEREDARAN TAHUN 2017

Transkripsi

1 1 Aditrim tablet Sulfametoksazoel 400 mg, Trimetoprim 80 mg LAMPIRAN OBAT YANG TIDAK MEMENUHI SYARAT MUTU / DITARIK DARI PEREDARAN TAHUN 2017 PT. Aditama Raya Farmindo TAHUN 2015 DKL B1 400N7S Sept 2018 PW TMS Kadar zat aktif, Disposisi Kabid : Sampling Bets Berbeda 2 Allopurinol Allopurinol 300 mg PT. Bernofarm GKL B1 TPH49042 Juli2018 PW TMS Uji Disolusi 3 Amoxycillin Forte SK Amoxycillin 250 mg/5ml PT. Holi GKL B Agt 2017 PW TMS Uji Volume Terpindahkan 4 Andalan Pil KB Levonorgestrel 0,15 mg Ethinylestradiol 0,03 mg PT. Harsen DKL A1 4E Mei 2019 PW TMS Keseragaman Kandungan 5 Andalan Pil KB Levonorgestrel 0,15 mg Ethinylestradiol 0,03 mg PT. Harsen DKL A1 4G Juli 2019 PW TMS Keseragaman Kandungan 6 Andalan Pil KB Levonorgestrel 0,15 mg Ethinylestradiol 0,03 mg PT. Harsen DKL A1 4H Agt 2019' PW TMS Keseragaman Kandungan 7 Antimab Tablet Dimenhidrinat 50 mg PT. Zenith ceutical DTL A Apr 2017 PW TMS Uji Disolusi 8 Aqua Bidestilata Cairan Steril Aqua Bidestilata PT. Lucas Djaja GKL A1 121J037 Okt 2017 PW TMS Uji ph, disposisi Kabid Sampling Bets yang berbeda 9 Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A s/d Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A s/d

2 11 Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A s/d Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A s/d Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A s/d Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A s/d

3 17 Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A s/d Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A s/d Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A s/d Aqua Pro Injectio 5 ml Aqua Pro Injectio GKL A s/d Asam Mefenamat 500 mg Tablet Salut Selaput Asam Mefenamat 500 mg GKL A1 Seluruh Bets PW Ditarik dari peredaran, karena mencantumkan tanggal kadaluarsa tidak sesuai dengan Nomor Izin Edar yang disetujui. 22 Betamin Tab salut gula Thiamin HCl 100 mg PT. Samco DBL A DH - PW Positif Asam Mefenamat 23 Betamin Tab salut gula Thiamin HCl 100 mg PT. Samco DBL A DHZ - PW Positif Asam Mefenamat 24 Bronkris Tablet Bromhexin Hidroklorida 8 mg PT. Graha DTL A1 TB169G Feb 2018 PW TMS Uji Disolusi (Sampling Apt. Mandiri Kota Mataram)

4 25 Buvanest Spinal 0,5% Heavy Inj 5 mg/ml PT. Kalbe DKL A1 PN Pembatalan izin edar untuk produk tersebut 26 Calortusin kaplet Parasetamol 500 mg, Dextromethorphan Hbr 15 mg, PPA HCl 15 mg dan CTM 2 mg 27 Carbazochrome Sodium Sulfonate I.V 28 Carbazochrome Sodium Sulfonate PT. Rama Emerald Multi Sukses PT Novell ceutical Lab. Untuk PT Etercon DTL A1 T3033AB Juli 2017 PW TMS Kadar PPA HCl GKL A1 Seluruh Bets - PW Stabilitas suhu GKL A s/d GKL A s/d GKL A s/d GKL A s/d

5 32 GKL A s/d GKL A s/d GKL A s/d GKL A s/d GKL A s/d

6 37 GKL A1 IL3J021 s/d IL3J GKL A1 IL3K031 s/d IL3K GKL A1 PH3J Duviral Kaplet Lamivudin 150 mg, Zidovudin 300 mg 41 Duviral Kaplet Lamivudin 150 mg, Zidovudin 300 mg 42 Efedrin tab 25 mg 1000 tab) PT. Kimia DKL A1 CC0328J Mar 2018 PW TMS Uji Disolusi PT. Kimia DKL A1 EC1111J Mei 2018 PW TMS Uji Disolusi Efedrin PT. Kimia GKL A1 - - PW Pembatalan izin edar untuk produk tersebut sejak tanggal 22 Februari Epinephrin Epinephrin PT Ethica GKL A1 Seluruh Bets - PW TMS Kadar & ph (penyimpanan) 44 Flamsy 50 Tablet Kalium Diklofenak 50 mg PT. Imedco Djaja DKL B Des 2017 PW Ditarik dari peredaran untuk nomor bets tersebut. 45 Gitri Suspensi Sulfametoksazoel 200 PT. Holi DKL A PW TMS Kadar Sulfametoksazol mg, Trimetoprim 40 mg 46 Heroflu kaplet Parasetamol 500 mg, Dextromethorphan Hbr 15 mg, PPA HCl 12,5 mg dan CTM 2 mg PT. Heroic DTL A Nov 2017 PW TMS Kadar CTM dan PPA serta TMS Uji Disolusi PPA

7 47 Heroflu kaplet Parasetamol 500 mg, Dextromethorphan Hbr 15 mg, PPA HCl 12,5 mg dan CTM 2 mg PT. Heroic DTL A Sept 2017 PW TMS Kadar CTM dan PPA 48 Hufadexon 0,5 mg kaplet Dexamethasone 0,5 PT. Gratia Husada DKL B1 K40163 Des 2018 PW TMS Uji Disolusi 49 Hufadexon 0,5 mg kaplet Dexamethasone 0,5 PT. Gratia Husada DKL B1 K40053 Apr 2018 PW TMS Uji Disolusi 50 Hufadexon 0,5 mg kaplet Dexamethasone 0,5 PT. Gratia Husada DKL B1 K40174 Des 2019 PW TMS Uji Disolusi 51 Hufadexon 0,5 mg kaplet Dexamethasone 0,5 PT. Gratia Husada DKL B1 K40044 Mar2019 PW TMS Uji Disolusi 52 Hufadexon 0,5 mg kaplet Dexamethasone 0,5 PT. Gratia Husada DKL B1 Seluruh Bets - PW TMS Kadar, kandungan, disolusi 53 Hufadexon 0,75 mg Dexamethasone 0,75 PT. Gratia Husada DKL A1 K60173 Agt2018 PW TMS Uji Disolusi kaplet 54 Hufadexon 0,75 mg kaplet Dexamethasone 0,75 PT. Gratia Husada DKL A1 K60073 Mei 18 PW TMS Uji Disolusi 55 Hydrochlorothiazide Tab Hydrochlorothiazide 25 GKL B Des2017 PW TMS Uji Disolusi mg 56 Hydrochlorothiazide Tab Hydrochlorothiazide 25 mg GKL A Sept 2017 PW TMS Uji Disolusi 57 Ifison Tablet Prednison 5 mg PT. Infarmind DKL A Juli 2017 PW TMS Uji Disolusi 58 Kadiflam 50 mg tablet Kalium Diklofenak 50 mg PT. Metiska DKL B Juli 2017 PW TMS Uji Disolusi, sudah dilakukan Voluntary Recall oleh Manufacturer berdasarkan Surat PBF PT. Penta Valent No. 39/PV- MTR/EXT/VI/2015 tanggal 10 Juni Kapsul Solathim Thiamphenicol 500 mg PT. Solas Indonesia DTL A1 KEV10 Mar 2018 PW TMS Uji Disolusi, hasil sampling BBPOM di Mataram di PBF SST Tanggal 19 Sept 2014, sudah terbit surat recall dari Pusat dan dibuatkan surat ke sarana

8 60 Kapsul Solathim Thiamphenicol 500 mg PT. Solas Indonesia DTL A1 KIV2 Juni 2018 PW TMS Uji Disolusi, hasil sampling BBPOM di Mataram di PBF SST Tanggal 19 Sept 2014, sudah terbit surat recall dari Pusat dan dibuatkan surat ke sarana 61 Kapsul Solathim Thiamphenicol 500 mg PT. Solas Indonesia DTL A1 KEV 8 Maret 2018 PW TMS Uji Disolusi, hasil sampling BBPOM di Mataram di PBF SST Tanggal 19 Sept 2014, sudah terbit surat recall dari Pusat dan dibuatkan surat ke sarana 62 Ketoconazole 200 mg Tablet Ketoconazole 200 mg PT. Novapharin GKL A Juni 2018 PW TMS Keseragaman Identitas Tablet 63 Lang Vit C PT. Eagle Indo DBL A1 64 Langdin 10% PT. Eagle Indo DBL A1 65 Licofel Kapsul Piroksikam 20 mg PT. Berlico Mulia DKL A1 CU95005 Mar 2019 PW TMS Uji Disolusi 66 Licofel Kapsul Piroksikam 20 mg PT. Berlico Mulia DKL A1 CU95009 Mar 2019 PW TMS Uji Disolusi 67 Licofel Kapsul Piroksikam 20 mg PT. Berlico Mulia DKL A1 JT95033 Okt 2018 PW TMS Uji Disolusi 68 Licofel Kapsul Piroksikam 20 mg PT. Berlico Mulia DKL A1 BU95004 Feb 2019 PW TMS Uji Disolusi 69 Licofel Kapsul Piroksikam 20 mg PT. Berlico Mulia DKL A1 FU95020 Juni 2019 PW TMS Uji Disolusi 70 Licofel Kapsul Piroksikam 20 mg PT. Berlico Mulia DKL A1 IU95024 Sept 2019 PW TMS Uji Disolusi

9 71 Licofel Kapsul Piroksikam 20 mg PT. Berlico Mulia DKL A1 DT95015 Apr 2018 PW TMS Uji Disolusi 72 Lifadrox Forte Cefadroxil 250 mg PT. Holi DKL B Apr 2018 PW TMS ph dan Kadar Air 73 Methylprednisolone 4 mg Methylprednisolone 4 mg GKL A Nov 2017 PW TMS Uji Disolusi tablet 74 Norit 125 mg kemasan PT. Eagle Indo DBL A2 kantong 12 tablet 75 Norit 125 mg kemasan PT. Eagle Indo DBL A3 pot plastik 100 tablet 76 Norit 125 mg kemasan PT. Eagle Indo DBL A5 pot plastik 20 tablet 77 Norit 125 mg kemasan PT. Eagle Indo DBL A4 pot plastik 50 tablet 78 Norit 125 mg kemasan PT. Eagle Indo DBL A6 pot plastik 500 tablet 79 Norit 125 mg kemasan PT. Eagle Indo DBL A1 tube 40 tablet 80 Novason Tablet Fenil butazon 200 mg PT. Novapharin DKL A Feb 2018 PW TMS Uji Disolusi 81 Obat Kumurine Cap Lang PT. Eagle Indo DBL A1 82 Obat Merah Cap Lang 2 PT. Eagle Indo DTL A1 % 83 OBH Cap Lang Botol PT. Eagle Indo DBL A1 100 ml 84 Omegtrim Sulfametoksazoel 200 PT. Mutifa DKL A PW TMS ph mg, Trimetoprim 40 mg 85 Omegtrim Sulfametoksazoel 200 PT. Mutifa DKL A PW TMS ph mg, Trimetoprim 40 mg 86 Ometilson tablet Metil Prednisolon 4 mg PT. Mutifa DKL A Mar 2018 PW TMS Keseragaman Kandungan 87 Otrivin 0.05% Nasal Drops PT. Novartis DTL A PW Leaflet tidak mencantumkan informasi posologi 88 Paracetamol Tab Paracetamol GBL A Des2018 PW TMS Uji Disolusi

10 89 Paracetamol Tab Paracetamol GBL A Des2018 PW TMS Uji Disolusi 90 Phenobarbital tab 30 mg 1000 tab) Phenobarbital PT. Kimia GPL A1 - - PW Pembatalan izin edar untuk produk tersebut sejak tanggal 22 Februari Prednison tablet Prednison PT. Novapharin GKL A Jan 2018 PW TMS Uji Disolusi, disposisi Kabid Sampling Bets yang berbeda 92 Prointi Suspensi Ibuprofen 100 mg/5ml PT. Inti Jaya Meta Ratna 93 Puyer Anak Sumang Cap PT. Eagle Indo Lang kemasan strip 400 mg 94 Puyer Sakit Kepala dan Influenza Cap Lang No. 45 PT. Eagle Indo DTL A Juli 2017 PW TMS ph DBL A1 DBL A1 95 Ranitidine Tablet Ranitidine 150 mg PT. Holi GKL A Apr 2017 PW TMS Pemerian Produk / Tablet 96 Rifampicin Kapsul Rifampicin GKL B Okt 2017 PW TMS Uji Disolusi 97 Salbutamol 4 mg Salbutamol 4 mg GKL B Sept 2017 PW TMS Uji Disolusi 98 Salbutamol 4 mg Salbutamol 4 mg GKL B Des 2017 PW TMS Uji Disolusi 99 Salbutamol 4 mg Salbutamol 4 mg GKL B Mei 2018 PW TMS Uji Disolusi 100 Salbutamol 4 mg Tablet Salbutamol 4 mg GKL B Des 2017 PW TMS Uji Disolusi 101 salep Kulit Cap Lang PT. Eagle Indo DBL A1 kemasan Pot 10 g 102 Samquinor Ciprofloxacin 500 mg PT Samco DKL A DF2 Jun-19 PW TMS Uji Disolusi, disposisi Kabid pantau batch yang sama, Sampling Bets yang berbeda 103 Simvastatin Kaplet Simvastatin PT. Graha GKL A1 UE132G Mei 2017 PW TMS Kadar 104 Solasic Kaplet Asam Mefenamat 500 mg PT. Solas Langgeng Sejahtera DKL A1 TIV44 Juni2019 PW TMS Waktu Hancur.

11 105 Tramadol 50 mg kapsul Tramadol 50 mg PT. Promedrahardjo si GKL A1 - - PW dan HK Pembatalan izin edar untuk produk tersebut 106 Tramadol Inj 50 mg/ml Tramadol 50 mg / ml GKL A s/d produksi 24 Maret Trihexyphenidyl Tablet 2 mg Trihexyphenidyl PT. Yarindo tama GKL A1 HK Pembatalan izin edar untuk produk tersebut sejak tanggal 27 April Trimol Kaplet Paracetamol 500 mg PT. Triman DBL A1 A4016 Jan 2019 PW TMS Uji Disolusi 109 Vosama Tetes Mata Betamethason Sodium Phosphate 1 mg 110 Xylastin Tablet Metoclopramide HCl 10 mg 111 Yusimox Forte SK Amoxycillin 250 mg/5ml PT. Ifars ceutical PT. Cendo ceutical Industries DKL A1 4V Juli 2017 PW TMS ph PT. Novapharin DKL A Jan 2018 PW TMS Uji Disolusi DKL B Mei 2017 PW TMS Kadar Air, Disp KaBid : Surat ke sarana TAHUN Amiclav amoxicillin ; Clavulanat PT. Gracia Pharmindo DKL A1 ME002 Mei 2018 PW TMS Kadar Amoxicillin 2 Amitripilin Amitriptilin 25 mg PT. Yarindo tama GKL A1 A14051S Sep-19 PW TMS keseragaman kandungan 3 Amitripilin Tablet Amitriptilin 25 mg PT. Yarindo tama GKL A1 A14051S Sep-19 PW TMS keseragaman kandungan (27 Juli 2016) 4 Amoxicillin Amoxicillin 500 mg PT. Phyto Kemo Agung GKL A1 YL91021 Maret 2018 PW TMS Uji Disolusi 5 Anastan Forte Kaplet Asam Mefenamat 500 mg PT. Gratia Husada DKL A1 K Agt 20 PW TMS Uji Disolusi 6 Anastan Forte Kaplet Asam Mefenamat 500 mg PT. Gratia Husada DKL A1 K Okt 20 PW TMS Uji Disolusi 7 Axofen Sirup Ibuprofen 100 mg PT. Sampharindo Perdana 8 Bravelle Serbuk Inj 75 IUdan - Ferring GmbH, Kiel, Pelarut Jerman / PT. Dipa lab Intersains, Jakarta DTL A1 BI 2771 Sept 2017 PW TMS ph DKI A1 - - PW Voluntary Recall

12 9 Brufen 600 mg Tablet - PT. Abbot Indonesia XP 20 Okt 17 PW Voluntary Recall 10 Brufen 600 mg Tablet - PT. Abbot Indonesia XP 21 Des 17 PW Voluntary Recall 11 Brufen 600 mg Tablet - PT. Abbot Indonesia XP 16 Mei 17 PW Voluntary Recall 12 Captopril 12,5 mg Tablet Captopril 12,5 mg PT. Kimia GKL A1 F120968B Juni 2017 PW TMS Kadar 13 Carbamazepine 200mg Carbamazepine 200mg GKL A Jan-19 PW TMS Uji Disolusi 14 Cataflam Fast Diclofenac Potassium 50 mg/sachet PT. Novartis Indonesia DKI A1 478N,490N,536 N - PW Kesalahan penulisan nama garam bahan aktif 15 Cefadroxil Tiap 5 ml mengandung PT. holi GKL A Jan-18 PW TMS Kadar Air Cefadroxil 125 mg 16 Cefixime 100mg Cefixime 100mg Global Medika Jakarta I GKL A1 BF5C002 Apr-18 PW TMS Uji Disolusi 17 Cendo Xitrol Neomycin 3.5 mg; Polymixin PT. Cendo Pharm Ind. DKL A1 5X PW TMS ph B Sulfate IU; 18 Cendo Xitrol Neomycin 3.5 mg; Polymixin PT. Cendo Pharm Ind. DKL A1 5X PW TMS ph B Sulfate IU; Dexametason 1 mg 19 Cendo Xitrol Neomycin 3.5 mg; Polymixin B Sulfate IU; Dexametason 1 mg PT. Cendo ceutical Ind. DKL A1 5X0525 Nov-17 PW TMS ph 20 Chloramphenicol Chlorampenicol 125mg/5mL PT. Bernofarm GKL A1 SCG24144 Jun-17 PW TMS ph 21 Ciprolex Ciprofloxacin HCl.H2O PT. Molex Ayus Pharm DKL A1 XM009 Mar-18 PW TMS Uji Disolusi 22 Citoneuron Kaplet Vit B1 100 mg, Vit B6 200 PT. Ciubros DBL A1 JN03K7A Okt - 18 PW TMS Kadar Vit. B12 mg, Vit B mcg 23 Co Amoxiclav Amoxicillin 500 mg; Tbk. GKL B1 AC4L104 Januari 2018 PW TMS Kadar Amoxicillin Clavulanic Acid 125 mg 24 Cydifar Cyproheptadine HCI 4 mg PT. Ifars ceutical DKL A2 - - PW TMS Uji Disolusi 25 Dexaharsen 0,5 kaplet, 20 strip 26 Dexaharsen 0,5 kaplet, 20 strip 27 Dexaharsen 0,5 kaplet, 20 strip 28 Dexaharsen 0,5 kaplet, 20 strip 29 Dexaharsen 0,5 mg kaplet, 250 kaplet 30 Dexaharsen 0,75 kaplet, 20 strip Deksametason 0,5 mg PT. Harsen DKL A1 5A Jan 20 PW TMS Kadar dan Keseragaman Kadar Deksametason 0,5 mg PT. Harsen DKL A1 4J Okt 19 PW TMS Kadar dan Keseragaman Kadar Deksametason 0,5 mg PT. Harsen DKL A1 4K Nov 19 PW TMS Kadar dan Keseragaman Kadar Deksametason 0,5 mg PT. Harsen DKL A1 4L Des 19 PW TMS Kadar dan Keseragaman Kadar Deksametason 0,5 mg PT. Harsen DKL A2 4G Okt 19 PW TMS Kadar dan Keseragaman Kadar Deksametason 0,75 mg PT. Harsen DKL B1 4F Juli - 19 PW TMS Kadar dan Keseragaman Kadar

13 31 Dexaharsen 0,75 kaplet, 20 strip Deksametason 0,75 mg PT. Harsen DKL B1 4J Okt - 19 PW TMS Kadar dan Keseragaman Kadar 32 Dexaharsen 0,75 kaplet, 20 strip Deksametason 0,75 mg PT. Harsen DKL B1 4L Des - 19 PW TMS Kadar dan Keseragaman Kadar 33 Dexamethason 0,5 mg Dexamethason 0,5 mg PT. holi B-PW Formula tidak stabil Tablet sd 34 Diazepam 2 mg Diazepam 2 mg Tbk. GPL A Sep-17 PW TMS Disolusi 35 Diphenhidramin HCl Diphenhidramin HCl 10 mg PT Lucas Djaja GKL A1 - - PW TMS ph 36 Diphenhidramin HCl Injeksi Diphenhidramin HCl 10 mg PT Lucas Djaja GKL A1 - - PW (13 Juli 2016) TMS ph 37 Domperidon Domperidon 10 mg PT. Novapharin ceutical GKL A Mei-19 PW TMS kadar 38 Epexol Syrup Ambroxol HCl 15 mg/5 ml PT. Sanbe DKL A1 SB1639,SE PW TMS Desain kemasan dus dan perbedaan tanggal kedaluarsa dengan persetujuan izin edar 39 Ezygard Forte - Promedrahardjo si Industry D0010, 13814D0020, - 58/PV-MTR/EXT/VI/2016 Strip menggembung 40 Flamsy 50 tablet Kalium Diklofenac 50 mg PT. Imedco Djaja DKL B PW TMS Keseragaman Kandungan 41 Flamsy 50 tablet Kalium Diklofenac 50 mg PT. Imedco Djaja DKL B PW TMS Keseragaman Kandungan 42 Flamsy 50 tablet Kalium Diklofenac 50 mg PT. Imedco Djaja DKL B PW TMS Keseragaman Kandungan 43 Flamsy 50 tablet Kalium Diklofenac 50 mg PT. Imedco Djaja DKL B PW TMS Keseragaman Kandungan 44 Flutrop Sirup Pseudoefedrin HCl 15 mg, Tripolidine HCl 1,25 mg PT. Tropica Mas DTL A1 IK1091 Nov 17 PW PW (29 Agustus 2016) TMS Kadar Tripolidine Dilakukan Triggered Sampling

14 45 Fungiderm Krim Klotrimazol 1% PT. Konimex DTL A1 A03 Mar 20 PW TMS Isi Minimum 46 Haloperidol 1,5mg Haloperidol 1,5mg GKL B Feb-19 PW TMS Uji Disolusi 47 Heroflu Kaplet Tiap kaplet mengandung Paracetamol 500 mg, Dekstromethrophan PT. Heroic DTL A dan seluruh bets produksi tahun 2015 dan 2016 Apr-19 PW (11 Agustus 2016) TMS kadar Dextromethorpan HBr 48 Hiclofen 100 kapsul Fenofibrate 100 mg PT. Harsen DKL A1 3E Mei 17 PW TMS Uji Disolusi 49 Hisacha Tiap tablet mengandung Glibenclamide 5 mg 50 Hisacha Tablet Tiap tablet mengandung Glibenclamide 5 mg PT. Yekatria DKL A1 5A506 Agt-20 PW TMS Uji Disolusi PT. Yekatria DKL A1 5A506 Agt-20 PW (13 Juli 2016) TMS Uji Disolusi 51 Hufadexon 0,5 mg Dexamethason 0.5 PT. Gratia Husada DKL B1 K40184 Des 19 PW TMS Uji Disolusi 52 Hufadexon 0,75 mg Dexamethason 0.5 PT. Gratia Husada DKL A1 K70124 Nov 19 PW TMS Uji Disolusi 53 Hufadexon 0,75 mg Dexamethason 0.5 PT. Gratia Husada DKL A1 K60122 Jun 17 PW TMS Uji Disolusi 54 Hufadexon 0,75 mg Tablet Deksametason 0,75 mg PT. Gratia Husada DKL A1 K dan seluruh bets Feb 20 PW Pemberhentian Sementara Keg. Produksi seluruh bets Hufadexon 0,75 mg dan Penarikan Produk 55 Hyperchol 100 kapsul Fenofibrate 100 mg PT. Ikapharmido Putramas 56 Ifibion Tablet Vit B1 100 mg, B6 200 mg, B mcg DKL A Jan - 19 PW TMS Uji Disolusi PT. Infarmind DBL A Mar 18 PW TMS Kadar Sianokobalamin 57 Ifitamol Ifitamol PBF PT. Hari Sehat DKL A Jul-17 PW TMS Uji Disolusi 58 Incidal OD Kapsul 10 mg Cetirizine Hydrochloride PT. Bayer Indonesia DKL A1 371A PW (6 Mei 2016) Obat Palsu 59 Ketokonazole 200 mg Tablet Ketokonazole 200 mg PT. Novapharin ceutical 60 Ketokonazole 200 mg Tablet Ketokonazole 200 mg PT. Novapharin ceutical GKL A Mar 19 PW TMS Pemerian Tablet GKL A Mar 19 PW TMS Pemerian Tablet

15 61 Lexapram Metoclopramida Hcl 5 mg PT. Molex Ayus Pharm DKL A1 VL032 Juli 2017 PW TMS Kadar 62 Lexavon Tablet Bromheksin HCl 8 mg PT. Molex Ayus DTL A1 XG004 Agt - 18 PW TMS Uji Disolusi 63 Lodomer Haloperidol 2 mg / ml PT. Mersifarma Tirmaku DKL A Mar-18 PW TMS ph Mercusana 64 Lodomer Drops 15 ml Haloperidol 2 mg / ml PT. Mersifarma Tirmaku Mercusana Masflu forte Masflu Forte Tablet Tiap tablet mengandung acetaminophen 500 mg; CTM Tiap tablet 2 mg mengandung acetaminophen 500 mg; CTM 2 mg DKL A Mar-18 PW (23 Juni 2016) TMS ph PT. Samco DTL B DM Nov-17 PW TMS Kadar dan Keseragaman Kandungan PPA HCl serta Keseragaman Kandungan CTM PT. Samco DTL B DM Nov-17 PW (13 Juli 2016) TMS Kadar dan Keseragaman Kandungan PPA HCl serta Keseragaman Kandungan CTM 67 Mecoticum Krim Ketokonazol 2% PT. Mecosin DKL A Sept - 17 PW TMS Isi Minimum 68 Metronidazol Metronidazol 500mg PT. Phyto Kemo Agung GKL B1 ZA Jan-19 PW TMS Uji Disolusi 69 Metronidazol Metronidazol 500mg PT. Phyto Kemo Agung GKL B1 ZB91266 Feb-19 PW TMS Uji Disolusi 70 Metronidazol Metronidazol 500mg PT. Phyto Kemo Agung GKL B1 YC Mar-18 PW TMS Uji Disolusi 71 Miniaspi Asetosal 80 mg PT. Mersifarma DKL A Agt 18 PW TMS Kadar Asetosal dan Asam Salisilat Bebas 72 Nasafed Tablet Pseudoephedrine HCl 60 mg, Tripolidine HCl 60 mg PT. Medikon Prima Laboratories DKL A1 I00266 Juni 2019 PW TMS Kadar dan Keseragaman Kadar Tripolidine HCl 73 Nizoral Tablet 200 mg Ketokonazol Taisho ceutical Indonesia DKL A1 IH PW (6 Mei 2016) Obat Palsu 74 Norvom Metoclopramida Hcl 10 mg PT Ifars Pharm DKL A /11090 Maret 2018 PW TMS Kadar 75 Nufaprim Suspensi Tiap 5 ml mengandung Sulfamethoxazole 200 mg, Trimethoprim 40 mg PT. Nufarindo ceutical Lab DKL A Feb 18 PW TMS Volume terpindahkan 76 Omegtrim Tiap 5 ml mengandung PT. Mutifa DKL A Jan-18 PW TMS ph Sulfametoksazol 200 mg dan Trimetoprim 40 mg 77 Omegtrim Suspensi 60 ml Tiap 5 ml mengandung Sulfametoksazol 200 mg dan Trimetoprim 40 mg 78 Omeprazole 20 mg Omeprazole 20 mg Industri si PT. Novaphrin cental Industres PT. Mutifa DKL A Jan-18 PW (23 Juni 2016) TMS ph GKL A Mei-19 PW TMS Kadar 79 Omestan Tablet Asam Mefenamat 500 mg PT. Mutifa DKL A Jul 20 PW TMS Uji Disolusi

16 80 Orphen Tablet Chlorpheniramine maleat 4 PT. Solas Langgeng DTL A1 TOV18 Okt - 19 PW TMS Kadar mg Sejahtera 81 Paracetamol Tiap 5 ml PT. Afi GBL A Sep-17 PW TMS volume terpindahkan mengandungparacetamol 120 mg 82 Paracetamol Tiap 5 ml PT. Afi GBL A1 D29502 Apr-18 PW TMS volume terpindahkan mengandungparacetamol 120 mg 83 Paracetamol Tiap 5 ml PT. Afi GBL A1 G39402 Juni 17 PW TMS volume terpindahkan mengandungparacetamol 120 mg 84 Paracetamol Tiap 5 ml PT. Afi GBL A1 J39401 Okt-17 PW TMS volume terpindahkan mengandungparacetamol 85 Paracetamol 500mg Paracetamol 500mg GBL A Nov PW TMS Uji Disolusi 86 Paracetamol Kaptab, Botol 1000 kaptab Paracetamol 500 mg. PT. Imfarmind Industri si GBL PW TMS Uji Disolusi 87 Paracetamol Sirup 60 ml Tiap 5 ml mengandungparacetamol 120 mg 88 Paracetamol Sirup 60 ml Tiap 5 ml mengandungparacetamol 89 Paracetamol Sirup 60 ml Tiap 5 ml mengandungparacetamol 90 Paracetamol Sirup 60 ml Tiap 5 ml mengandungparacetamol 91 Pehacain Inj Lidocain HCl 20 mg, Epinefrin 0,0125 mg PT. Afi GBL A Sep-17 PW (20 Juni 2016) TMS volume terpindahkan PT. Afi GBL A1 D29502 Apr-18 PW (20 Juni 2016) TMS volume terpindahkan PT. Afi GBL A1 G39402 Juni 17 PW TMS volume terpindahkan (20 Juni 2016) PT. Afi GBL A1 J39401 Okt-17 PW TMS volume terpindahkan (20 Juni 2016) PT. Phapros DKL A Apr 18 PW TMS ph 92 Poncohist hydrochlorthiazide 4 mg PT. Mensa Bina Sukses DKL A Januari 2019 PW TMS Uji Disolusi 93 Prednison Prednison 5 mg PT. Afi Industri GKL A Okt-17 PW TMS Uji Disolusi si 94 Prednison Tablet Prednison 5 mg PT. Afi GKL A1 I40404 Okt 17 PW TMS Uji Disolusi 1000 tab) 95 Prednison Tablet (botol Prednison 5 mg PT. Novapharin GKL A Mar 18 PW TMS Uji Disolusi 1000 tab) ceutical 96 Prednison Tablet (botol Prednison 5 mg PT. Inti Jaya Meta Ratna GKL A Des 17 PW TMS Uji Disolusi 1000 tab) Pharmindo 97 Prednison Tablet (botol Prednison 5 mg PT. Inti Jaya Meta Ratna GKL A Maret 17 PW TMS Uji Disolusi 1000 tab) Pharmindo 98 Prodiabet Tablet Glibenclamide 5 mg PT. Bernofarm DKL A1 TPH40641 Juli 17 PW TMS Uji Disolusi 99 Pyrantel Suspensi Pyrantel Pamoat 125 mg PT. Holi GTL A Juni - 17 PW TMS ph

17 100 Pyrazinamide 500 mg Pyrazinamide 500 mg PT. Kimia GKL A1 A130068B Januari 2018 PW TMS Disolusi 101 Renabetic Tablet Glibenclamid 5 mg PT. Pratapa Nirmala DKL A1 EI0761 Sept - 18 PW TMS Uji Disolusi 102 Renacardon 5 Tablet Enalapril Maleat 5 mg PT. Pratapa Nirmala DKL B1 EI 1031 Sept - 18 PW TMS Kadar dan Keseragaman Kandungan 103 Renvol 50 Tablet - PT. Otto ceutical Industries - 0D0337 Agt-17 PW (20 Juni 2016) TMS Uji Disolusi 104 Renvol 50 Tablet - PT. Otto ceutical Industries - 0D0337 Okt-17 PW (20 Juni 2016) TMS Uji Disolusi 105 Renvol 50 Tablet - PT. Otto ceutical Industries 106 Renvol 50 Tablet - PT. Otto ceutical Industries - 0D0337 Agt-17 PW TMS Uji Disolusi - 0D0337 Okt-17 PW TMS Uji Disolusi 107 Salaf 2-4 Salep Acid Salicylicum 2%, Sulfur Praecipitatum 4%, Vaselinum Album 47% 108 Sanmag Suspensi Tiap 5 ml mengandung Al(OH)3 325 mg, Mg Trisilikat 325 mg, Simetikom 25 mg 109 Sanmag Suspensi Tiap 5 ml mengandung Al(OH)3 325 mg, Mg Trisilikat 325 mg, Simetikom 25 mg PT. Nusantara Beta GBL A Feb - 19 PW TMS Isi Minimum PT. Sanbe D PF1789 Juni - 17 PW TMS Kadar PT. Sanbe D PF1800 Juni - 17 PW TMS Kadar 110 Sanmag Suspensi Tiap 5 ml mengandung PT. Sanbe D PH1529 Agt - 17 PW TMS Kadar Al(OH)3 325 mg, Mg 111 Simvastatin 20 mg kaplet Simvastatin 20 mg PT. Graha GKL A1 UE132G Mei 2017 PW TMS Kadar 112 Sintrol Simvastatin 10 mg PT. Solas Langgeng Sejahtera DKL A1 TAW 94 Januari 2018 PW TMS Kadar, Keseragaman Kandungan, Keragaman Bobot 113 Sirup Sidiadryl Expectorant Sirup Sidiadryl Expectorant PT. Bernofarm DTL A1 SCD11144 Mar-18 PW Tidak Memenuhi Syarat 114 Solathim Thiamphenicol 500 mg PT. Solas Langgeng Sejahtera DKL A1 KMZ 9 Agustus 2017 PW TMS Uji Disolusi 115 Solathim Kapsul Thiamphenicol 500 mg PT. Solas Langgeng Sejahtera DKL A1 KFV4 Apr-18 PW TMS Uji Disolusi 116 Stomach Al(OH)3; Mg(OH)2; Simetikon PT. Mutifa DBL A Agustus 2018 PW TMS kadar Al(OH)2 117 Sulfadiazine Tablet Sulfadiazine 500 mg PT. Aditama Raya D P7SW Okt-18 PW TMS Disolusi Farmindo 118 Versibet-1 Glimepiride 1 mg PT Harsen DKL A1 3G Juli 2017 PW TMS Uji Disolusi 119 Vitamin B Complek IPI Vitamin B Complek IPI PT. Supra Ferbindo DBL A1 O80055 Agt-17 PW A TMS PK Thiamin HCI dan PK Vitamin B Complek

18 120 Zonifar kaplet Fenilbutazon 200 mg PT. Ifars ceutical Laboratories DKL A Agt 19 PW TMS Uji Disolusi JANUARI Ambroxol Sirup Botol 60 ml Tiap 5 ml mengandung Ambroxol HCl 15 mg GKL A A Feb 19 Feb 19 Juni 19 B-PW TMS ph PT. Novapharin 2 Asam Mefenamat Kaplet Asam Mefenamat 500 mg PT. Bernofarm DKL A1 TSC20744 TSK72743 TSC21944 TSK71843 TSL TSF57444 Asam Mefenamat 500 mg Asam Mefenamat Kaplet PT. Novapharin GKL A1 4 Bisoprolol Tablet 5 Carbazochrome Sod. Sulfonate I.V Inj. 50 mg/10 ml Bisoprolol Hemifumarat 5 mg Carbazochrome Sod. Sulfonate I.V PT. Novell ceutical Lab PT. Novell ceutical Lab untuk PT. Etercon GKL A1 GKL A1 16D164, 17D249, 17C089, 17B182, 17F209 16D162, 16D163, 16E152, 15I098 Feb 20 Sept 19 'Feb 20 Sept 19 Okt 19 Mei 20 B-PW TMS Uji Disolusi Jan 20 B-PW TMS Uji Disolusi E8F009 Jun 17 B-PW B-PW , B- PW TMS Keseragaman Kandungan TMS Pemerian (perubahan warna) 6 Farmoten 12,5 Tablet Captopril 12,5 mg PT. Pratapa Nirmala DKL B1 - - B-PW No. Reg telah kedaluarsa 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 DTL A1 S4066AE Des 18 B-PW TMS Kadar 8 Furosemide Tablet Furosemide 40 mg PT. Sampharindo GKL A1 DG0801 Jul 19 B-PW TMS Uji Disolusi 9 Ibuprofen Suspensi Botol 60 ml Tiap 5 ml mengandung Ibuprofen 100 mg PT. Rama Emerald Multi Sukses GTL A1 S2040AF Mei 19 B-PW TMS Kadar FEBRUARI 2017

19 10 Glyceryl Guaiacolate Tablet (botol 1000 tablet) Guafenesin 100 mg / tablet PT. Ciubros GBL A1 AO05T14B Jan 19 B-PW TMS Uji Disolusi 11 Glyceryl Guaiacolate Tablet (botol 1000 tablet) Guafenesin 100 mg / tablet PT. Ciubros GBL A1 IO09T14B Sept 19 B-PW TMS Uji Disolusi 12 Ciprofloxacin Tab 500 mg Ciprofloxacin 500 mg/ Tab PT. Bernofarm GKL A1 - - B-PW NIE GKL A1 telah habis masa berlaku pada 29 November 2015