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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 64-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-4833859-7/1/1 22-Dec-2011 64AAK99 3006736350 Kejing Cleaning Products Co Ltd China
 
G32-0132869-4/52/1 21-Dec-2011 64AAL20 3007083765 Sabon Industries Ltd Israel
 
109-0844139-6/1/1 20-Dec-2011 64ACR99 2219682 DSHealthcare Inc. United States
 
MA7-0689624-2/1/19 23-Dec-2011 64BAY24 3004567236 Carnival Cruise Lines Bahamas
 
112-0645670-4/12/1 13-Dec-2011 64BCB25 3004409997 Roche Qfsa Brazil
 
112-0645670-4/3/1 13-Dec-2011 64BCB25 3005047667 Astra Zeneca S.A. de C.V. Mexico
 
112-1173391-5/1/2 28-Dec-2011 64BCE25 3007692005 Boehringer Ingelheim Pharma GMBH & Co Germany
 
M21-0745031-6/2/1 04-Dec-2011 64BCS24 3005144955 Chemo S.A. Lugano Branch Switzerland
 
NU7-0019373-0/1/1 07-Dec-2011 64ECY99 3009031579 Wuxi Accobio Biotech Inc. China
 
112-9092063-0/1/1 27-Dec-2011 64GAB19 3008547621 Laboratorios Gyrea Spain
 
112-3387503-3/1/3 07-Dec-2011 64GCB21 3004157683 Pfizer Consumer Health Care Mexico
 
112-3388616-2/1/1 07-Dec-2011 64GCB29 3006212599 Bayer De Mexico Sa De Cv Mexico
 
112-0982250-6/1/1 16-Dec-2011 64GDA07 3008312353 Alfa Wassermann Spa Italy
 
112-2473611-1/1/1 12-Dec-2011 64GDA19 3008942084 Katie Mclean United Kingdom
 
112-0986220-5/1/1 27-Dec-2011 64GDB99 3008780382 Laboratorios Ela Mexico S.A. Mexico
 
M21-0744965-6/1/1 04-Dec-2011 64HDA01 3006094247 Research Pharmaceutical Co Ltd China
 
M21-0745031-6/1/1 04-Dec-2011 64HDA99 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-1244417-3/1/9 28-Dec-2011 64LAF02 3004081307 Cipla Limited India
 
112-1244417-3/1/11 28-Dec-2011 64LAF02 3004081307 Cipla Limited India
 
MA7-0689624-2/1/23 23-Dec-2011 64LAY19 3004567236 Carnival Cruise Lines Bahamas
 
112-1944630-4/1/1 12-Dec-2011 64LBJ06 3005446834 MSD (Thailand) Ltd. Thailand
 
112-8426442-4/1/2 13-Dec-2011 64LBO37 3002348847 Janssen Cilag Ltd United Kingdom
 
M21-0744947-4/2/1 04-Dec-2011 64LCA41 3008367099 Shanghai Trifecta Pharma Ltd. China
 
112-4560317-5/4/1/E 05-Dec-2011 64LCJ08 3002624237 Glaxo Saudi Arabia Ltd. Saudi Arabia
 
112-4560317-5/4/1/D 05-Dec-2011 64LCJ67 3002624237 Glaxo Saudi Arabia Ltd. Saudi Arabia
 
112-3406340-7/1/2 07-Dec-2011 64LCK37 3003932458 Alcon Laboratorios Mexico
 
112-0461830-5/1/1 13-Dec-2011 64LCO03 3006282172 Pharmaniaga Berhad Malaysia
 
UPS-4395259-3/1/1 08-Dec-2011 64LCY61 3004078138 Merck S.A. Colombia
 
112-3406340-7/1/6 07-Dec-2011 64LDH16 3006535127 Rimsa Saginomya Sa De Mexico
 
112-4813658-7/4/1/F 09-Dec-2011 64LDJ06 3003705104 Shalina Laboratories Limited India
 
112-4813658-7/4/1/I 09-Dec-2011 64LDJ06 3009226578 GLOWHITE LTD Italy
 
112-4813658-7/4/1/B 09-Dec-2011 64LDJ67 3003762660 PANDAS PHARMACEUTICALS LTD. Italy
 
112-4813658-7/4/1/C 09-Dec-2011 64LDJ67 3003762660 PANDAS PHARMACEUTICALS LTD. Italy
 
112-4813658-7/4/1/E 09-Dec-2011 64LDJ67 3003762660 PANDAS PHARMACEUTICALS LTD. Italy
 
112-4813658-7/4/1/H 09-Dec-2011 64LDJ67 3009226578 GLOWHITE LTD Italy
 
112-1115239-7/3/1/A 13-Dec-2011 64LDO67 3002624237 Glaxo Saudi Arabia Ltd. Saudi Arabia
 
112-3406340-7/1/1 07-Dec-2011 64LDY16 3006535127 Rimsa Saginomya Sa De Mexico
 
112-3406340-7/1/4 07-Dec-2011 64LDY64 3006535127 Rimsa Saginomya Sa De Mexico
 
WFE-0071868-0/2/1 12-Dec-2011 64LDY67 3001611875 Alconon Laboratorios, S.A. De C.V. Mexico
 
112-9111546-1/1/2 27-Dec-2011 64LOZ19 3007249445 Trutina Pharmacy Canada
 
112-4690780-5/1/1 16-Dec-2011 64MCK14 3007148938 Serono Laboratories Inc United States
 
112-3852784-5/1/1 28-Dec-2011 64RIY99 3003831171 Catalent Germany Schomdorf GmbH Germany
 
UPS-4357924-8/1/1 19-Dec-2011 64RPL99 3008489744 Despatch United Kingdom
 
MA7-0689624-2/1/28 23-Dec-2011 64SAY08 3004567236 Carnival Cruise Lines Bahamas
 
506-0824072-2/1/1 01-Dec-2011 64TAR99 2210396 Novartis Pharmaceuticals Corp. United States
 
506-0824072-2/2/1 01-Dec-2011 64TAR99 2210396 Novartis Pharmaceuticals Corp. United States
 
112-5212365-3/1/1 12-Dec-2011 64TBA99 3009259125 Torexin D O O Belarus
 
112-5212365-3/2/1 12-Dec-2011 64TBK99 3009259125 Torexin D O O Belarus
 
112-4598654-7/1/1 05-Dec-2011 64TDE09 3000189692 Novartis Pharma Ag Switzerland
 
112-5596451-6/1/2 13-Dec-2011 64UIY99 3008102815 Rakesh Dutt India
 
112-2082549-6/1/3 12-Dec-2011 64XBY06 3008897189 Darrow Laboratorios Brazil
 
112-2025272-5/1/1 12-Dec-2011 64XBY06 3006272162 KIK Holdco Company, Inc. Canada
 
112-0933669-7/1/1 16-Dec-2011 64XCC11 3008773689 Roche, Venez. Venezuela
 
UPS-4491379-2/1/2 29-Dec-2011 64XCY11 3009260387 Maria Elsy Salas Colombia
 
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