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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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-6977293-8/1/1 05-Jan-2011 62AIJ04 3006741774 Vivin Laboratories Pvt Ltd India
 
XXX-0272039-0/1/3 10-Jan-2011 62CCY65 3002806761 Chemical Works of Gedeon Richter Plc., Budapest Site Hungary
 
D52-8907268-3/1/1/B 21-Jan-2011 62FBJ46 3008068944 Patanjali Ayurved India
 
112-5324409-3/1/8 06-Jan-2011 62GAA99 3005208011 Divya Pharmacy Yog India
 
112-5324409-3/1/9 06-Jan-2011 62GAA99 3008068944 Patanjali Ayurved India
 
112-5324409-3/1/10 06-Jan-2011 62GAA99 3005208011 Divya Pharmacy Yog India
 
112-5324409-3/1/11 06-Jan-2011 62GAA99 3005208011 Divya Pharmacy Yog India
 
XXX-0270775-1/1/5 03-Jan-2011 62GAY41 3010221253 LABORATORIOS LOPEZ, S.A DE C.V. El Salvador
 
112-5324409-3/1/1 06-Jan-2011 62GAZ99 3005208011 Divya Pharmacy Yog India
 
112-5324409-3/1/2 06-Jan-2011 62GAZ99 3005208011 Divya Pharmacy Yog India
 
112-5324409-3/1/3 06-Jan-2011 62GAZ99 3005208011 Divya Pharmacy Yog India
 
112-5324409-3/1/4 06-Jan-2011 62GAZ99 3005208011 Divya Pharmacy Yog India
 
112-5324409-3/1/5 06-Jan-2011 62GAZ99 3005208011 Divya Pharmacy Yog India
 
112-5324409-3/1/6 06-Jan-2011 62GAZ99 3005208011 Divya Pharmacy Yog India
 
112-5324409-3/1/7 06-Jan-2011 62GAZ99 3005208011 Divya Pharmacy Yog India
 
XXX-0270884-1/1/2 03-Jan-2011 62GBY41 3003916517 Unipharma International, SA Guatemala
 
XXX-0270884-1/1/3 03-Jan-2011 62GBY41 3006127003 Caplin Point Laboratories India
 
112-5220453-6/1/1 06-Jan-2011 62GCA18 3008041115 Laboratorios Kendrick Sa De Cv Mexico
 
AEK-8360828-7/2/1 06-Jan-2011 62GCA42 3008594208 Santosh Desmpande India
 
112-6496660-0/1/1 05-Jan-2011 62GCA49 3006260175 Tobufar Bvba Belgium
 
M21-0742776-9/1/1 07-Jan-2011 62GCB94 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-7702893-5/1/1 04-Jan-2011 62GDB41 3002807985 Reckitt Benckiser Healthcare (U.K.) Limited United Kingdom
 
112-7702893-5/1/2 04-Jan-2011 62GDB41 3002807985 Reckitt Benckiser Healthcare (U.K.) Limited United Kingdom
 
112-6729470-3/1/1 06-Jan-2011 62GDB42 3002807585 Mepha LLC Switzerland
 
XXX-0272029-1/1/3 10-Jan-2011 62GDY18 3006347951 Merck Sa De Cv Mexico
 
315-7447390-1/9/1 07-Jan-2011 62HBL99 3004604751 ENVIRON SKIN CARE (PTY) LTD (Prev. Environ Cosmeceutics CC) South Africa
 
315-7447390-1/12/1 07-Jan-2011 62HBL99 3004604751 ENVIRON SKIN CARE (PTY) LTD (Prev. Environ Cosmeceutics CC) South Africa
 
315-7447390-1/18/1 07-Jan-2011 62HBL99 3004604751 ENVIRON SKIN CARE (PTY) LTD (Prev. Environ Cosmeceutics CC) South Africa
 
AEK-8600919-4/1/2 10-Jan-2011 62ICK86 1451914 Abbott Laboratories United States
 
AEK-8358985-9/3/2 07-Jan-2011 62KCA10 3008562907 Fahul Karim Bangladesh
 
XXX-0271872-5/1/3 31-Jan-2011 62KCB11 3005104060 Unipharm Guatemala
 
112-7652515-4/1/1 04-Jan-2011 62KOY10 3003663256 Zhejiang Xianju Pharmaceutical Co., Ltd. China
 
CDX-0052163-5/1/3 19-Jan-2011 62MBJ08 3002898912 Delon Laboratories Canada
 
CDX-0052163-5/1/5 19-Jan-2011 62MBJ08 3002898912 Delon Laboratories Canada
 
112-7932033-0/1/1 04-Jan-2011 62MBO08 3001278543 V & S Pharmaceuticals Trinidad & Tobago
 
KG2-0527460-1/1/8 26-Jan-2011 62MBY01 2210396 Novartis Pharmaceuticals Corp. United States
 
940-0174564-8/1/7 11-Jan-2011 62MBY08 3005139860 Pharm Invest Jv Ukraine
 
820-0579163-5/2/1 18-Jan-2011 62MCR01 3008529481 Duellberg-Konzentra Gmbh & Co Germany
 
820-0579163-5/1/1 18-Jan-2011 62MCR08 3008529481 Duellberg-Konzentra Gmbh & Co Germany
 
940-0174564-8/1/2 11-Jan-2011 62MDA08 3005139860 Pharm Invest Jv Ukraine
 
940-0174564-8/1/17 11-Jan-2011 62MDL08 3005139860 Pharm Invest Jv Ukraine
 
940-0174564-8/7/1 11-Jan-2011 62MDL08 3005139860 Pharm Invest Jv Ukraine
 
112-7213713-7/1/1 05-Jan-2011 62MIY01 3007511302 Trinity Health Canada
 
112-5155246-3/1/1 07-Jan-2011 62NAJ99 3006647804 Valeant Pharmaceutics United States
 
AEK-8360964-0/4/1 06-Jan-2011 62NBF99 3008596148 Sd Sawheny India
 
AEK-8360828-7/1/1 06-Jan-2011 62OCA14 3008594208 Santosh Desmpande India
 
112-6519713-0/1/1 05-Jan-2011 62OCL26 3002958920 Merck Frosst Canada Canada
 
UPS-0575691-7/1/2 06-Jan-2011 62OCY12 3008670237 Paola Doddiane Italy
 
112-7663173-9/2/1 04-Jan-2011 62OCY14 3001203985 Pfizer Canada Inc. - Kirkland, QC Administrative Site Canada
 
XXX-0272047-3/1/5 10-Jan-2011 62OCY14 3005637424 Tecnoquimica Sa Colombia
 
UPS-0888114-2/1/1 25-Jan-2011 62OCY14 3004152231 Tecnoquimicas Colombia
 
XXX-0272047-3/1/6 10-Jan-2011 62OCY28 3006475565 Genfar Colombia
 
112-6587546-1/2/1 06-Jan-2011 62ODA09 3003023771 Roche Pharmaceuticals Canada
 
112-7946722-2/1/1 04-Jan-2011 62ODA26 1000360120 Merck Sharp & Dohme-Chibret France
 
M21-0742779-3/1/1 07-Jan-2011 62ODZ37 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-7841933-1/1/1/C 03-Jan-2011 62SBL03 3005696816 Med Care Srl Italy
 
112-6727277-4/1/2 06-Jan-2011 62TCA06 3005029956 Torrent Pharmaceuticals Ltd. India
 
112-6601951-5/1/2 05-Jan-2011 62TDA06 3007056005 Pharmeks Dis Ticaret Ltd Sti Turkey
 
112-6601951-5/1/1 05-Jan-2011 62TDA06 3007056005 Pharmeks Dis Ticaret Ltd Sti Turkey
 
112-0074951-8/1/1 06-Jan-2011 62TIS06 3003369663 Cadila Healthcare Ltd India
 
112-0096107-1/1/1 06-Jan-2011 62TIS06 3003696998 Zydus Cadila Healthcare Limited India
 
112-7013891-3/1/1 05-Jan-2011 62VDJ18 3007487514 Luilna Brazil
 
112-6506322-5/1/1 05-Jan-2011 62VIA99 3000264888 Patheon Inc. - Toronto Region Operations Canada
 
112-0250451-5/1/1 13-Jan-2011 62VIZ24 3003096793 Jetpharma S.A. Switzerland
 
UPS-0589461-9/5/15 03-Jan-2011 62WAL17 3002394266 Helena Rubinstein S.A. France
 
FN5-0119443-8/4/1 24-Jan-2011 62WBY99 3002133569 Inspiration Mfg. & Trade Co. China
 
112-7594340-8/1/1 04-Jan-2011 62YAA07 3003933424 Pharex Philippines
 
112-7703685-4/1/1 04-Jan-2011 62ZCP04 3002806761 Chemical Works of Gedeon Richter Plc., Budapest Site Hungary
 
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