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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
112-2774015-6/1/1 14-Apr-2004 66ACY01 1000383130 Bayer S.P.A. Italy
 
112-2482192-6/3/1 12-Apr-2004 66BAY05 3004423487 Prollenium Medical Technologies Inc. Canada
 
112-2725018-0/2/1 13-Apr-2004 66BAY05 3004455210 Roche Laboratory Mexico
 
AEK-6953438-2/1/1 28-Apr-2004 66BCA19 3004430445 Rokar International Ltd Israel
 
112-2724045-4/1/1 13-Apr-2004 66BLY99 3004455031 Surge Equip Ltd Ireland
 
AEK-6961277-4/2/1 28-Apr-2004 66CBF99 3003593894 Vaidya Balendu Prakash India
 
W04-0237393-4/3/1 22-Apr-2004 66FBJ99 3001350836 Ganpati Exports India
 
AEK-6953783-1/1/1 28-Apr-2004 66FDA99 3003593894 Vaidya Balendu Prakash India
 
AEK-6953783-1/1/2 28-Apr-2004 66FDR99 3003593894 Vaidya Balendu Prakash India
 
AEK-6949092-4/2/1 21-Apr-2004 66GCK25 3004393917 Al Zubair General Trading Est. United Arab Emirates
 
112-2692527-9/3/1 13-Apr-2004 66JCB01 3004451212 Publicidad Garnier Bbso Costa Rica
 
112-2775771-3/1/1 14-Apr-2004 66JCY02 3003975869 Hermes Pharmeceuti Canada
 
AEK-6952383-1/4/2 01-Apr-2004 66JDA01 3004424089 Direct Medicine Pharmacy South Africa
 
411-8316624-2/1/1 09-Apr-2004 66KCS99 3003494606 Yick-Vic Chemicals & Pharmaceuticals (HK) LTD Hong Kong SAR
 
AEK-6948832-4/3/1 28-Apr-2004 66MBA03 3004378457 Raj Kumar Thukral India
 
AEK-6955338-2/4/4 01-Apr-2004 66MCA03 3004439779 Ricardo Mabarb Portugal
 
AEK-6945209-8/6/1 28-Apr-2004 66MCA03 3004359679 Dr, Vidya Ohatker India
 
AEK-6948297-0/2/2 28-Apr-2004 66MCA99 3004375457 Kmk Murthy India
 
112-2593866-1/1/1 12-Apr-2004 66MCK36 3004439566 Ken Holmes Canada
 
112-2563805-5/1/1 12-Apr-2004 66MCY75 3004435696 Ache Laboratories Farmaceuticos Brazil
 
AEK-6952383-1/3/2 01-Apr-2004 66MDA09 3004424089 Direct Medicine Pharmacy South Africa
 
112-2616800-3/1/2 12-Apr-2004 66MIY98 3003081334 Conseil De L'Europe France
 
112-2978429-3/1/1 07-Apr-2004 66NCA02 1000656034 Eli Lilly And Company Limited United Kingdom
 
442-7506107-3/2/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/6/2 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/4/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/8/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/12/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/16/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/20/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/24/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/27/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/29/2 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/31/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/35/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/39/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
442-7506107-3/43/3 06-Apr-2004 66PAJ99 3007543742 Shiga Plant Procter & Gamble Japan
 
808-0113107-1/42/1 29-Apr-2004 66PAJ99 3002766978 Affiliated Food Stores Inc. Philippines
 
595-3136442-6/1/1 09-Apr-2004 66PBL99 3004153844 Quiksilver Australia Australia
 
AEK-6962583-4/1/3 28-Apr-2004 66SCA28 3004477622 Ketan B Shah United Arab Emirates
 
AEK-6945749-3/1/1 28-Apr-2004 66SCA48 3004362730 Prareen Sharker Pillar India
 
AEK-6962583-4/1/2 28-Apr-2004 66SCB24 3004477622 Ketan B Shah United Arab Emirates
 
AEK-6960316-1/2/1 22-Apr-2004 66SCB48 3004473369 Rahat Ishaq Pakistan
 
582-6728690-4/1/1/A 01-Apr-2004 66V99 3004471688 Evela Nieves Mexico
 
582-6728690-4/1/1/B 01-Apr-2004 66V99 3004471688 Evela Nieves Mexico
 
582-9067416-7/1/1 02-Apr-2004 66V99 3004215869 Fytoterapicos A Cura Com Brazil
 
582-9067416-7/1/3 02-Apr-2004 66V99 3004215869 Fytoterapicos A Cura Com Brazil
 
ND7-0014956-7/1/1 27-Apr-2004 66V99 3004287962 "Jermuk" CJSC Armenia
 
582-9398113-0/1/1 27-Apr-2004 66V99 3004516947 ANDERSON CONSULTANCY United Arab Emirates
 
112-3864386-9/1/1 26-Apr-2004 66VAA99 3004043416 Exelso Lab Dominican Republic
 
DO7-0085558-1/1/1 28-Apr-2004 66VAA99 3004486910 Voronova Kazakhstan
 
582-9270705-6/1/1 08-Apr-2004 66VAK99 3004477315 Ozone Ayurvedics India
 
112-2482192-6/1/1 12-Apr-2004 66VAK99 3004423487 Prollenium Medical Technologies Inc. Canada
 
429-0766551-9/1/11 29-Apr-2004 66VAM99 3002420457 Cultech Ltd United Kingdom
 
112-2836555-7/1/1 08-Apr-2004 66VAP99 3004468727 Aventis Phama Sa Guatemala
 
112-2965602-0/1/3 09-Apr-2004 66VAP99 3004485673 Bourgeois Sport Belgium
 
112-2965602-0/1/8 09-Apr-2004 66VAP99 3004485673 Bourgeois Sport Belgium
 
112-2816847-2/1/1 13-Apr-2004 66VAP99 3004466246 Pharma Gmbh Germany
 
112-2725018-0/4/1 13-Apr-2004 66VAP99 3004455209 Promeco Mexico
 
112-2814016-6/1/1 14-Apr-2004 66VAP99 3004465974 Physicians Choice United States
 
AEK-6963102-2/4/1 28-Apr-2004 66VAR99 3004362461 Kottakkal Arya Vaidya Sala India
 
AEK-6963102-2/5/1 28-Apr-2004 66VAR99 3004362461 Kottakkal Arya Vaidya Sala India
 
582-9068942-1/1/7 08-Apr-2004 66VAY99 3004474577 Maria G. Arcos Ramirezz Mexico
 
112-2629555-8/1/1 12-Apr-2004 66VAY99 3004444049 J. Suyarna India
 
112-2800564-1/1/1 12-Apr-2004 66VAY99 3004127611 Bayer S.A. Brazil
 
XXX-0080876-7/1/1 20-Apr-2004 66VAY99 3004188441 Thanh Dao Lacquerwares Vietnam
 
112-2623361-7/1/1 21-Apr-2004 66VAY99 3003625752 Glaxo Smith Kline Mexico Sa De Cv Mexico
 
823-0101040-9/10/1 28-Apr-2004 66VAY99 3004195755 Holgard Trading Co Pakistan
 
EU6-0027622-1/1/9 15-Apr-2004 66VBA99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
EU6-0027622-1/1/10 15-Apr-2004 66VBA99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
EU6-0027622-1/1/12 15-Apr-2004 66VBA99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
EU6-0027622-1/1/13 15-Apr-2004 66VBA99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
EU6-0027622-1/1/18 15-Apr-2004 66VBA99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
EU6-0027622-1/1/1 15-Apr-2004 66VBB99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
EU6-0027622-1/1/3 15-Apr-2004 66VBB99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
XXX-0079082-5/1/1 09-Apr-2004 66VBE99 3004430257 Lai Yung Shang Sung Fen Tang Ltd China
 
EU6-0027622-1/1/5 15-Apr-2004 66VBE99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
EU6-0027622-1/1/6 15-Apr-2004 66VBE99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
EU6-0027622-1/1/7 15-Apr-2004 66VBE99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
EU6-0027622-1/1/8 15-Apr-2004 66VBE99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
EU6-0027622-1/1/17 15-Apr-2004 66VBE99 3003898365 Centro Botanico Azteca SA Mexico
 
HD8-0067114-5/3/31 09-Apr-2004 66VBJ99 3003211847 Kim Jeong Moon Aloe Inc Korea, Republic Of (South)
 
U47-0426258-1/1/1/G 14-Apr-2004 66VBJ99 3004144647 TOPSYNE France
 
U47-0426258-1/1/1/A 14-Apr-2004 66VBJ99 3005497840 Virgin Beauty Industries Nig Ltd Nigeria
 
U47-0426258-1/1/1/B 14-Apr-2004 66VBJ99 3005497840 Virgin Beauty Industries Nig Ltd Nigeria
 
U47-0426258-1/1/1/H 14-Apr-2004 66VBJ99 3003576344 SIVOP Ivory Coast
 
U47-0426258-1/1/1/I 14-Apr-2004 66VBJ99 3003576344 SIVOP Ivory Coast
 
U47-0426258-1/1/1/J 14-Apr-2004 66VBJ99 3003576344 SIVOP Ivory Coast
 
U47-0426258-1/1/1/K 14-Apr-2004 66VBJ99 3004144657 BEAUTY FAIR LABORATORIES France
 
U47-0426258-1/1/1/L 14-Apr-2004 66VBJ99 3004144660 GARO HASBANIAN France
 
EU6-0027622-1/3/2 15-Apr-2004 66VBL99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
EU6-0027622-1/3/3 15-Apr-2004 66VBL99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
WT8-0306826-9/1/1 02-Apr-2004 66VBR99 3004409168 Tsumura & Co Shizuoka Plant Japan
 
555-0359335-6/27/2 06-Apr-2004 66VBR99 3004096041 Splash Corporation Philippines
 
555-0359335-6/27/3 06-Apr-2004 66VBR99 3004096041 Splash Corporation Philippines
 
WUG-0124456-4/9/3 09-Apr-2004 66VBR99 3000281905 Bombay Export India
 
FS2-1042076-6/3/1 22-Apr-2004 66VBR99 3004212572 Rich & Wealth Int'L Sales Co., Ltd Taiwan
 
EU6-0027622-1/2/1 15-Apr-2004 66VBU99 3003898365 Centro Botanico Azteca SA Mexico
 
EU6-0027622-1/2/3 15-Apr-2004 66VBU99 1000599639 Plantas Medicinales Anahuac, S.A. De C.V. Mexico
 
XXX-0080248-9/1/1 05-Apr-2004 66VBY99 3004475851 Inocencia Cruz Mexico
 
582-9068942-1/1/1 08-Apr-2004 66VBY99 3004474577 Maria G. Arcos Ramirezz Mexico
 
WUG-0124456-4/7/1 09-Apr-2004 66VBY99 3000281905 Bombay Export India
 
WUG-0124456-4/8/6 09-Apr-2004 66VBY99 3000281905 Bombay Export India
 
WUG-0124456-4/9/1 09-Apr-2004 66VBY99 3000281905 Bombay Export India
 
WUG-0124456-4/9/2 09-Apr-2004 66VBY99 3000281905 Bombay Export India
 
WUG-0124456-4/9/4 09-Apr-2004 66VBY99 3000281905 Bombay Export India
 
112-2530649-7/1/1 11-Apr-2004 66VBY99 3003805283 Fumedica Gmbh Germany
 
AKG-0102627-5/1/1/B 23-Apr-2004 66VBY99 3003741150 Dasherb Corp China
 
AKG-0102627-5/1/1/C 23-Apr-2004 66VBY99 3003741150 Dasherb Corp China
 
AEK-6627276-2/1/2 23-Apr-2004 66VBY99 3004486300 Shengqi Medicine Technology Development Ltd Macau SAR
 
DO7-0085055-8/1/1 02-Apr-2004 66VCA99 3004459577 Bynamic Network Luxembourg
 
AEK-6627935-3/1/1 27-Apr-2004 66VCA99 3004430487 Win Demesta Depele Indonesia
 
DO7-0084754-7/1/1 28-Apr-2004 66VCA99 3000163767 Victoria-Apotheke Switzerland
 
DO7-0084859-4/1/1 28-Apr-2004 66VCA99 3004449191 Dr. P.K. Biswas India
 
DO7-0084861-0/1/1 28-Apr-2004 66VCA99 3000163767 Victoria-Apotheke Switzerland
 
DO7-0084862-8/1/1 28-Apr-2004 66VCA99 3004449738 Turkiye Sinai Kalkinha Turkey
 
DO7-0084959-2/1/1 28-Apr-2004 66VCA99 3004272092 Wockhardt Ltd. India
 
DO7-0085340-4/1/1 28-Apr-2004 66VCA99 3004473287 Ans Express Services Pvt Ltd India
 
DO7-0084857-8/1/1 28-Apr-2004 66VCK99 3004449189 R Hin Lindt Switzerland
 
112-2852750-3/1/1 08-Apr-2004 66VCP99 3004146756 Kin Inc Canada
 
112-2801875-0/1/1 09-Apr-2004 66VCP99 3004464597 Newport Pharmaceutical Costa Rica
 
112-2469245-9/1/1 11-Apr-2004 66VCP99 3004204724 Biopak Limited Canada
 
112-2482192-6/6/1 12-Apr-2004 66VCP99 3004423487 Prollenium Medical Technologies Inc. Canada
 
112-2482192-6/7/1 12-Apr-2004 66VCP99 3004423487 Prollenium Medical Technologies Inc. Canada
 
112-2644845-4/1/1 12-Apr-2004 66VCP99 3004445737 Beeden Internation India
 
112-2644845-4/1/2 12-Apr-2004 66VCP99 3004445737 Beeden Internation India
 
112-2745483-2/1/1 13-Apr-2004 66VCP99 3003983652 Kestrel Opthalmics United Kingdom
 
112-2755962-2/1/1 13-Apr-2004 66VCP99 3005043162 Merz Pharmaceuticals GmbH Germany
 
112-2655241-2/1/1 13-Apr-2004 66VCP99 3002372120 Msd Netherlands
 
112-2717703-7/1/1 13-Apr-2004 66VCP99 3004454139 Mer Sha Costa Rica
 
112-2717703-7/2/1 13-Apr-2004 66VCP99 3004454140 Medisantk Germany
 
112-2717703-7/3/1 13-Apr-2004 66VCP99 3004187918 Genfar Sa Colombia
 
112-2717703-7/4/1 13-Apr-2004 66VCP99 3004454144 Grupo De Feria Congreso Y Evento Panama
 
112-2762046-5/1/1 13-Apr-2004 66VCP99 3004459929 Value Telecom Sa Switzerland
 
112-2717703-7/3/2 14-Apr-2004 66VCP99 3004454138 Halver De Colombia Colombia
 
112-2859771-2/1/1 14-Apr-2004 66VCP99 3004471195 Saanich Pharmacy Co Ltd Canada
 
112-2754664-5/1/1 14-Apr-2004 66VCP99 3004458606 Psdm Zambia
 
112-2817130-2/1/1 14-Apr-2004 66VCP99 3001178266 Vitamed Inc Israel
 
112-2707527-2/1/1 20-Apr-2004 66VCP99 3004453966 Srinivasulu, T India
 
112-2707527-2/2/1 20-Apr-2004 66VCP99 3004453966 Srinivasulu, T India
 
112-2743259-8/1/1 20-Apr-2004 66VCP99 3004457188 Dhanavantnari Ayurredic India
 
112-2743259-8/2/1 20-Apr-2004 66VCP99 3004457188 Dhanavantnari Ayurredic India
 
112-2743259-8/3/1 20-Apr-2004 66VCP99 3004457188 Dhanavantnari Ayurredic India
 
112-2743259-8/4/1 20-Apr-2004 66VCP99 3004457188 Dhanavantnari Ayurredic India
 
112-2743259-8/5/1 20-Apr-2004 66VCP99 3004457188 Dhanavantnari Ayurredic India
 
112-2874724-2/1/1 30-Apr-2004 66VCP99 3004185043 Roche Consumer Health Switzerland
 
112-2971159-3/1/1 30-Apr-2004 66VCP99 3004486346 Boehringer Ingelheim S A Colombia
 
073-0077652-8/33/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/34/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/35/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/36/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/37/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/39/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/38/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/40/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/41/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/42/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/43/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/44/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
073-0077652-8/45/1 21-Apr-2004 66VCS99 1000325291 Maneesha Agencies India
 
AEK-6961939-9/1/1 28-Apr-2004 66VCS99 3004474283 Al Alfghani Co Jordan
 
AEK-6962641-0/1/1 28-Apr-2004 66VCS99 3004478186 Mary Greene Liberia
 
XXX-0080281-0/1/3 20-Apr-2004 66VCY99 3004477098 Floro Soto Argueta Mexico
 
DO7-0084810-7/1/1 28-Apr-2004 66VDA99 3004448037 First Express India
 
DO7-0084809-9/1/1 28-Apr-2004 66VDA99 3004272092 Wockhardt Ltd. India
 
DO7-0084925-3/1/1 28-Apr-2004 66VDA99 3004453576 Dr. Devendra Prasad India
 
DO7-0085215-8/1/1 28-Apr-2004 66VDA99 3004461442 Dtdc India
 
DO7-0085216-6/1/1 28-Apr-2004 66VDA99 3004467187 Muthu Health Center India
 
DO7-0085217-4/1/1 28-Apr-2004 66VDA99 3004467182 Cetra Medecin Chile
 
344-0690847-4/10/1/A 14-Apr-2004 66VDL99 3003372447 S H International India
 
344-0690847-4/10/1/B 14-Apr-2004 66VDL99 3003372447 S H International India
 
DO7-0085219-0/1/1 28-Apr-2004 66VDL99 3004180139 Diouck Alioune Cameroon
 
582-9151163-2/1/1 14-Apr-2004 66VDP99 3004458187 R. Kammsheidt Germany
 
582-9068942-1/1/6 08-Apr-2004 66VDY99 3004474577 Maria G. Arcos Ramirezz Mexico
 
112-2715926-6/1/1 21-Apr-2004 66VDY99 3004453965 Mistry Aspi India
 
112-2906564-4/1/1 08-Apr-2004 66VIA99 3004476891 Curran Dr Terry Canada
 
112-1197075-1/1/1 21-Apr-2004 66VIE99 3004100722 Dr. Nandlan Tiwari Pharmaceuticals India
 
112-2482192-6/2/1 12-Apr-2004 66VIP99 3004423487 Prollenium Medical Technologies Inc. Canada
 
112-2482192-6/4/1 12-Apr-2004 66VIP99 3004423487 Prollenium Medical Technologies Inc. Canada
 
112-2713447-5/1/1 13-Apr-2004 66VIP99 3004453710 Hadii Moussa South Africa
 
561-0073103-5/37/1 06-Apr-2004 66YAY99 3004029171 Pagoda Philippines Philippines
 
561-0073103-5/37/2 06-Apr-2004 66YAY99 3004096041 Splash Corporation Philippines
 
561-0073103-5/37/3 06-Apr-2004 66YAY99 3003268373 Trinidad Cosmetic Lab Philippines
 
561-0073103-5/39/1 06-Apr-2004 66YAY99 3004096041 Splash Corporation Philippines
 
W69-1179645-7/1/3 07-Apr-2004 66YBL99 3003598505 Taiwan Biotech Company Limited Taiwan
 
W69-1182377-2/1/2 29-Apr-2004 66YBL99 3003598505 Taiwan Biotech Company Limited Taiwan
 
W69-1183223-7/1/2 29-Apr-2004 66YBL99 3003598505 Taiwan Biotech Company Limited Taiwan
 
AQ1-3001104-4/1/1 15-Apr-2004 66YBQ99 3004456109 Heredia France
 
551-2898886-7/1/1 23-Apr-2004 66YDY99 3002628529 Pharmascience Inc. Canada
 
112-2678768-7/2/1 13-Apr-2004 66YRY99 3003593847 William Soro Canada
 
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