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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 66-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-4307824-8/1/1 09-Jan-2012 66BAY99 3008740316 Rama Yogaswara Indonesia
 
112-5553836-0/1/1 24-Jan-2012 66BBY05 3009301398 Della Perca Canada
 
UPS-4967297-1/1/1 12-Jan-2012 66BCS99 3008389606 Borneo Botanicals Indonesia
 
XXX-0176504-0/1/2 04-Jan-2012 66JCA01 3004438317 GlaxoSmithKline Pharmaceuticals Limited India
 
112-6815583-9/1/1 12-Jan-2012 66JCA05 3007853804 Erfa Belgium
 
112-8248433-0/1/1 12-Jan-2012 66JCB01 3003241097 Abbott Canada
 
AEK-8390027-0/4/2 06-Jan-2012 66MCA09 3009241718 Mr Madan Paul India
 
112-6053116-0/2/3 31-Jan-2012 66MCY86 3006469196 Sandoz Pty Ltd Australia
 
UPS-4968986-8/1/2 31-Jan-2012 66NCY02 3003812585 Catalent Pharma Solutions Limited United Kingdom
 
112-6053116-0/2/1 31-Jan-2012 66NCY03 3009380097 Astrazeneca Australia
 
316-0618988-9/2/6 18-Jan-2012 66PAJ99 3008812558 Shahnaz Ayurvedics (Noida) India
 
FV4-5037194-6/1/5 06-Jan-2012 66PBL99 3007292644 Kim Jeong Moon Aloe Co., Ltd. Korea, Republic Of (South)
 
112-5654892-0/1/1 13-Jan-2012 66PBL99 3008110507 Recipte For Men Ab Sweden
 
112-4849980-3/3/1 06-Jan-2012 66SCB27 3004828442 Evans Med Plc Nigeria
 
UPS-4634533-2/1/1 05-Jan-2012 66SCY27 3009269363 Mercedes Patricia Hurtado Colombia
 
112-3619185-9/1/1 05-Jan-2012 66VAA99 3009026025 Qing Hai Pharmacy Factory China
 
655-1602537-0/3/1 12-Jan-2012 66VAA99 3008957760 Chinoin Limited Hungary
 
UPS-4984599-9/2/1 17-Jan-2012 66VAE99 3005273424 Allimax Int Ltd United Kingdom
 
UPS-4646888-6/1/1 31-Jan-2012 66VAH99 3009263519 Benando Ginseng Canada
 
UPS-3923352-9/1/1 05-Jan-2012 66VAL99 3006622904 Caregen Co.,Ltd. Korea, Republic Of (South)
 
112-7168261-3/1/1/A 07-Jan-2012 66VAL99 3003221709 Atrium Innovations Inc. Canada
 
112-7168261-3/1/2/A 07-Jan-2012 66VAL99 3003221709 Atrium Innovations Inc. Canada
 
112-7168261-3/1/2/B 07-Jan-2012 66VAL99 3003221709 Atrium Innovations Inc. Canada
 
112-7168261-3/1/1/B 07-Jan-2012 66VAL99 3003221709 Atrium Innovations Inc. Canada
 
UPS-4984599-9/1/1 17-Jan-2012 66VAL99 3005273424 Allimax Int Ltd United Kingdom
 
AEK-8388099-3/1/1/A 20-Jan-2012 66VAL99 3009202429 James A Mahoi Sierra Leone
 
OHL-0090137-5/1/2 23-Jan-2012 66VAO99 3007821703 Cat Media Pty Limited Australia
 
660-2511120-5/16/1 12-Jan-2012 66VAY99 3009929146 Tit-Bit Foods (India) Pvt. Ltd. India
 
112-4675772-3/1/1 06-Jan-2012 66VBA99 3009185841 Ajmera Herbals Limited India
 
655-1602537-0/1/1 12-Jan-2012 66VBA99 3008957682 Aventis Farma Limited India
 
KM6-0054829-1/2/1 11-Jan-2012 66VBJ99 3009222637 Keval Exports Pvt Limited India
 
KM6-0054829-1/2/2 11-Jan-2012 66VBJ99 3009222637 Keval Exports Pvt Limited India
 
AZZ-2101786-9/1/6 23-Jan-2012 66VBJ99 3006742012 Asia Beauty Cosmetic Co Ltd Taiwan
 
AZZ-2101786-9/1/7 23-Jan-2012 66VBJ99 3006742012 Asia Beauty Cosmetic Co Ltd Taiwan
 
AZZ-2101786-9/1/8 23-Jan-2012 66VBJ99 3006742012 Asia Beauty Cosmetic Co Ltd Taiwan
 
112-7863462-5/1/1/C 07-Jan-2012 66VBL99 3008409572 Dinas Homeopathic Clinic Canada
 
112-7863462-5/1/2/B 07-Jan-2012 66VBL99 3008409572 Dinas Homeopathic Clinic Canada
 
112-7863462-5/1/1/B 07-Jan-2012 66VBL99 3008409572 Dinas Homeopathic Clinic Canada
 
112-8234125-8/1/1 12-Jan-2012 66VBL99 3007295113 Apimab Laboratoires France
 
112-8234125-8/1/2 12-Jan-2012 66VBL99 3007295113 Apimab Laboratoires France
 
112-8234125-8/1/3 12-Jan-2012 66VBL99 3007295113 Apimab Laboratoires France
 
112-8234125-8/2/1 12-Jan-2012 66VBL99 3007295113 Apimab Laboratoires France
 
112-8234125-8/2/2 12-Jan-2012 66VBL99 3007295113 Apimab Laboratoires France
 
112-8234125-8/2/3 12-Jan-2012 66VBL99 3007295113 Apimab Laboratoires France
 
144-5026904-1/2/2 31-Jan-2012 66VBL99 3006224993 Laboratoires Ndv Belgium
 
EBX-0802349-5/12/1 23-Jan-2012 66VBS99 3004328659 AABHAR INTERNATIONAL India
 
112-5591539-4/1/1 05-Jan-2012 66VBY99 3009193581 Smith Meyers Laboratories Singapore
 
300-8445719-9/9/1/B 11-Jan-2012 66VBY99 3005702809 Tootsi Impex Inc Canada
 
300-8445719-9/9/1/C 11-Jan-2012 66VBY99 3005702809 Tootsi Impex Inc Canada
 
D53-1115087-9/1/4 12-Jan-2012 66VBY99 3006329097 Laboratoire Dr Reiner Janka France
 
D53-1115087-9/1/5 12-Jan-2012 66VBY99 3006329097 Laboratoire Dr Reiner Janka France
 
D53-1115087-9/1/7 12-Jan-2012 66VBY99 3006329097 Laboratoire Dr Reiner Janka France
 
D53-1115087-9/1/9 12-Jan-2012 66VBY99 3006329097 Laboratoire Dr Reiner Janka France
 
D53-1115087-9/1/11 12-Jan-2012 66VBY99 3006329097 Laboratoire Dr Reiner Janka France
 
D53-1115087-9/1/18 12-Jan-2012 66VBY99 3006329097 Laboratoire Dr Reiner Janka France
 
D53-1115087-9/1/19 12-Jan-2012 66VBY99 3006329097 Laboratoire Dr Reiner Janka France
 
D53-1115087-9/1/20 12-Jan-2012 66VBY99 3006329097 Laboratoire Dr Reiner Janka France
 
D53-1115087-9/1/21 12-Jan-2012 66VBY99 3006329097 Laboratoire Dr Reiner Janka France
 
UPS-1698439-8/1/1 18-Jan-2012 66VBY99 3009151672 INAT-FARMA Russia
 
G81-2008343-7/3/1 19-Jan-2012 66VBY99 3003991741 Lycon Cosmetics Australia
 
EBX-0802349-5/9/4 23-Jan-2012 66VBY99 3004328659 AABHAR INTERNATIONAL India
 
112-5591165-8/1/1 23-Jan-2012 66VBY99 3009193581 Smith Meyers Laboratories Singapore
 
112-5591194-8/1/1 23-Jan-2012 66VBY99 3009193581 Smith Meyers Laboratories Singapore
 
112-5591393-6/1/1 23-Jan-2012 66VBY99 3009193581 Smith Meyers Laboratories Singapore
 
112-5591476-9/1/1 23-Jan-2012 66VBY99 3009193581 Smith Meyers Laboratories Singapore
 
112-5591517-0/1/1 23-Jan-2012 66VBY99 3009193581 Smith Meyers Laboratories Singapore
 
112-5591173-2/1/1/B 25-Jan-2012 66VBY99 3009193581 Smith Meyers Laboratories Singapore
 
XXX-0176507-3/1/3 04-Jan-2012 66VCA99 3006781192 Acme Formulation Pyt Ltd India
 
XXX-0176507-3/1/6 04-Jan-2012 66VCA99 3002806851 Dr. Reddy's Laboratories Ltd, CTO Unit 1 India
 
XXX-0176507-3/1/4 04-Jan-2012 66VCA99 3005505872 Abbott Healthcare Pvt. Ltd. India
 
XXX-0176507-3/1/9 04-Jan-2012 66VCA99 1000185722 Merck Sharp & Dohme Italia Spa Italy
 
112-6891599-2/1/4 12-Jan-2012 66VCC99 3006111326 Farmalab Industrias Quimicas Brazil
 
112-5584855-2/1/1 13-Jan-2012 66VCC99 3006656062 Glaxo Smith Kline Canada
 
112-5584855-2/3/1 13-Jan-2012 66VCC99 3008102147 Lisan Costa Rica
 
112-5584855-2/2/1 13-Jan-2012 66VCC99 1000549797 Merck Mexico, S.A. Mexico
 
112-5584855-2/4/1 13-Jan-2012 66VCC99 3007009946 Gentar Colombia
 
655-1602537-0/5/1 12-Jan-2012 66VCJ99 3008309084 Open Joint-Stock Company "Lubnypharm" Ukraine
 
112-5697626-1/1/1 07-Jan-2012 66VCR99 3010125008 SHANGHAI WASETA INTERNATIONAL TRADING CO., LTD. China
 
F23-9054287-6/20/1 06-Jan-2012 66VCS99 3008179628 Shavit Natural Quality Product Israel
 
UPS-4455727-6/1/1 10-Jan-2012 66VCS99 3009239039 Kawaldeep Bajwa Canada
 
UPS-4667251-1/1/1 30-Jan-2012 66VCS99 3009272332 C/O Mail Boxes Etc. United Kingdom
 
UPS-4667251-1/2/1 30-Jan-2012 66VCS99 3009272332 C/O Mail Boxes Etc. United Kingdom
 
UPS-4716165-4/1/1 04-Jan-2012 66VCY99 3004252894 Hebei Huarong Pharmaceutical Co.,Ltd China
 
112-7780324-7/2/1 06-Jan-2012 66VCY99 3008401050 Alcon Chile
 
AEK-8390413-2/1/1 06-Jan-2012 66VCY99 3009248745 D Prabhu India
 
DO7-8258408-3/1/1 06-Jan-2012 66VCY99 3009238180 Kneer Gmbh Fenster Und Turen Germany
 
GEO-6403109-5/1/1 18-Jan-2012 66VCY99 1000132620 Holland America Line - United States
 
GEO-6403148-3/1/1 24-Jan-2012 66VCY99 1000135041 Bellegrove Medical Supply United States
 
940-0175354-3/1/1 27-Jan-2012 66VCY99 3008045057 Best-pharm Ltd. Russia
 
655-1602537-0/4/1 12-Jan-2012 66VDA99 3008325306 SIC "Borshchahivskiy Chemical Pharmaceutical Plant" CJSC Ukraine
 
655-1602537-0/15/1 12-Jan-2012 66VDA99 3008831151 Jsc "Luganskiy Chemical-Pharmaceutical Plant" Ukraine
 
112-8575569-4/1/1 12-Jan-2012 66VDL99 3002594358 Laboratorium Prof Dr H Dyckerhoff Gmbh & Co Germany
 
655-1602537-0/2/1 12-Jan-2012 66VDO99 3008616485 Balkanpharma-Troyan AT Bulgaria
 
DZ1-0437240-1/25/1 09-Jan-2012 66VDR99 3004071113 Kijbanlue Multi-Food Co., Ltd Thailand
 
DZ1-0437240-1/48/1 09-Jan-2012 66VDR99 3004071113 Kijbanlue Multi-Food Co., Ltd Thailand
 
554-8706524-9/1/1 20-Jan-2012 66VDS99 3007852961 Seppic France
 
M21-0744806-2/4/1/E 09-Jan-2012 66VDY99 3006477060 Silicium Espana Spain
 
M21-0744806-2/4/1/F 09-Jan-2012 66VDY99 3006477060 Silicium Espana Spain
 
112-5116605-9/1/2 12-Jan-2012 66VDY99 3007231204 P A Benjamin Mfg Co Jamaica
 
112-5116605-9/1/3 12-Jan-2012 66VDY99 3008343737 Immuno Venture Products Limited Jamaica
 
112-5116605-9/2/1 12-Jan-2012 66VDY99 3009249051 J Stickland Jamaica
 
112-5116605-9/3/1 12-Jan-2012 66VDY99 3009249052 Alston Garrard United Kingdom
 
XXX-0176667-5/3/1 12-Jan-2012 66VDY99 3008007437 Unknown Multiple Countries (PODS ONLY)
 
371-4229050-3/1/1/B 13-Jan-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229050-3/1/1/A 13-Jan-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229050-3/1/1/C 13-Jan-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229050-3/1/1/D 13-Jan-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229050-3/1/1/E 13-Jan-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229050-3/1/6/A 13-Jan-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229050-3/1/3/C 13-Jan-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
XXX-0176707-9/2/1 13-Jan-2012 66VDY99 3009232915 Anhui Medipharm China
 
XXX-0176731-9/1/2 20-Jan-2012 66VDY99 3001014732 Multiple manufacturers Multiple Countries (PODS ONLY)
 
XXX-0176744-2/1/2 20-Jan-2012 66VDY99 3008007437 Unknown Multiple Countries (PODS ONLY)
 
XXX-0176750-9/3/1 20-Jan-2012 66VDY99 3001007513 Multiple Manufacturers Multiple Countries (PODS ONLY)
 
XXX-0176752-5/3/1 20-Jan-2012 66VDY99 3001005140 Multiple manufacturers Multiple Countries (PODS ONLY)
 
XXX-0176755-8/3/1 20-Jan-2012 66VDY99 3001005140 Multiple manufacturers Multiple Countries (PODS ONLY)
 
XXX-0176756-6/3/1 20-Jan-2012 66VDY99 3001005140 Multiple manufacturers Multiple Countries (PODS ONLY)
 
XXX-0176757-4/3/1 20-Jan-2012 66VDY99 3001005140 Multiple manufacturers Multiple Countries (PODS ONLY)
 
XXX-0177033-9/2/1 20-Jan-2012 66VDY99 3009300182 Houndufarma S.A. DE C.V. Honduras
 
XXX-0177036-2/3/1 20-Jan-2012 66VDY99 3007391890 S.C. Sandoz S.R.L. Romania
 
XXX-0177038-8/3/1 20-Jan-2012 66VDY99 3003822109 Laboratorios Fardel El Salvador
 
XXX-0177044-6/3/1 20-Jan-2012 66VDY99 3003934722 Genericos Lab El Salvador
 
XXX-0177045-3/3/1 20-Jan-2012 66VDY99 3001027464 UNKNOWN Guatemala
 
UPS-6809303-1/1/1 23-Jan-2012 66VDY99 3008861675 Ci Premier Sas Colombia
 
AWJ-0111259-3/1/10 23-Jan-2012 66VDY99 3006278664 Newton Everett United States
 
XXX-0176546-1/2/16 24-Jan-2012 66VDY99 3003880909 Laboratorios Ceguel Nicaragua
 
XXX-0176546-1/2/17 24-Jan-2012 66VDY99 3009200877 Laboratorios Menarini, SA Nicaragua
 
XXX-0176546-1/2/19 24-Jan-2012 66VDY99 3003579793 Laboratorios Vijosa S.A de C.V. El Salvador
 
XXX-0176546-1/2/20 24-Jan-2012 66VDY99 3003917875 LAFAR LAB El Salvador
 
XXX-0176546-1/2/39 24-Jan-2012 66VDY99 3003579793 Laboratorios Vijosa S.A de C.V. El Salvador
 
XXX-0176546-1/2/40 24-Jan-2012 66VDY99 3003916517 Unipharma International, SA Guatemala
 
112-5980261-3/1/1 07-Jan-2012 66VIK99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
112-5513950-8/1/1 05-Jan-2012 66VIL99 3009296842 Logomed Pharma Germany
 
112-8213835-7/1/1 07-Jan-2012 66VIL99 3008449604 Laboratorio Unidad Medica Integr Colombia
 
112-9208938-4/1/1 07-Jan-2012 66VIP99 3008560041 International Homeopatic Pharmac Mexico
 
506-0823993-0/1/1 18-Jan-2012 66VIY99 3002653483 Novartis Pharma Stein AG Switzerland
 
506-0823993-0/2/1 18-Jan-2012 66VIY99 3002653483 Novartis Pharma Stein AG Switzerland
 
UPS-4891626-2/1/1/A 24-Jan-2012 66VKL99 3009239986 Immunall Ltd United Kingdom
 
UPS-4891626-2/1/1/B 24-Jan-2012 66VPL99 3009239986 Immunall Ltd United Kingdom
 
CDF-0039738-3/1/1/A 05-Jan-2012 66YBY99 1250045 Tender Corporation United States
 
CDF-0039738-3/1/1/B 05-Jan-2012 66YBY99 1250045 Tender Corporation United States
 
J34-0066346-7/5/4 06-Jan-2012 66YC99 3007650246 Uniliver Thai Holding Co.,Ltd Thailand
 
112-4482332-9/1/1 06-Jan-2012 66YCY99 3009185841 Ajmera Herbals Limited India
 
ES6-4008679-0/26/1 25-Jan-2012 66YCY99 3004116897 Mondey Holding Peach Brand Co Ltd Thailand
 
XXX-0176745-9/2/1 20-Jan-2012 66YDY99 3008007437 Unknown Multiple Countries (PODS ONLY)
 
XXX-0176746-7/3/1 20-Jan-2012 66YDY99 3008007437 Unknown Multiple Countries (PODS ONLY)
 
XXX-0176749-1/3/1 20-Jan-2012 66YDY99 3008007437 Unknown Multiple Countries (PODS ONLY)
 
112-5879722-8/1/1 07-Jan-2012 66YIS99 3003769920 Bioniche Life Sciences Inc Canada
 
BUP-1535972-5/1/1 17-Jan-2012 66YIY99 3003387535 Lohmann Therapie-Systeme AG Germany
 
BUP-1535972-5/2/1 17-Jan-2012 66YIY99 3003387535 Lohmann Therapie-Systeme AG Germany
 
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