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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
506-0824005-2/1/1 22-Nov-2011 62ALP99 3002653483 Novartis Pharma Stein AG Switzerland
 
506-0824005-2/2/1 22-Nov-2011 62ALP99 3002653483 Novartis Pharma Stein AG Switzerland
 
MA7-0689310-8/6/1 17-Nov-2011 62CAY30 3004567236 Carnival Cruise Lines Bahamas
 
MA7-0689310-8/6/15 17-Nov-2011 62CAY30 3004567236 Carnival Cruise Lines Bahamas
 
MA7-0689310-8/6/53 17-Nov-2011 62CAY30 3004567236 Carnival Cruise Lines Bahamas
 
MA7-0689310-8/6/22 17-Nov-2011 62CAY65 3004567236 Carnival Cruise Lines Bahamas
 
112-4781875-5/2/1 21-Nov-2011 62CCB65 3004272092 Wockhardt Ltd. India
 
112-4540644-7/2/1 08-Nov-2011 62CCC65 3005847055 Actavis Group Ltd Iceland
 
112-9174269-3/1/1 02-Nov-2011 62CCY99 3007861661 Genfar Colombia
 
112-9174269-3/1/3 02-Nov-2011 62CCY99 3007861661 Genfar Colombia
 
112-9174269-3/1/2 02-Nov-2011 62CCY99 3007861660 American Generis Colombia
 
112-4253490-2/1/1 21-Nov-2011 62CIR35 3009150201 Euticals Spa Italy
 
BRQ-0087922-2/2/3 09-Nov-2011 62FAL99 3004397191 TECNO BOTANICA DE MEXICO SA DE CV Mexico
 
XXX-0175973-8/1/1 14-Nov-2011 62GAB41 3009054721 Rebecca Mccowan Canada
 
BRQ-0087922-2/2/2 15-Nov-2011 62GAL99 3004397191 TECNO BOTANICA DE MEXICO SA DE CV Mexico
 
112-4676494-3/1/1 21-Nov-2011 62GCP90 3004437293 Novartis Switzerland
 
FL2-0037767-7/1/1 23-Nov-2011 62GCS18 3003743917 Kairav Chemicals Ltd India
 
112-4144675-1/1/1 15-Nov-2011 62GCY18 3009138281 Novartis Pharma Germany
 
UPS-4040269-1/1/3 08-Nov-2011 62GCY59 3009179005 Peter Gulow Germany
 
M21-0744704-9/1/1 23-Nov-2011 62GDL18 3008367099 Shanghai Trifecta Pharma Ltd. China
 
112-9791541-8/1/1 02-Nov-2011 62GQK89 3004205525 Merck S.A. Venezuela
 
144-4960656-8/1/1 30-Nov-2011 62HAL99 3008308044 Tc Bentfield Bv Netherlands
 
144-4960656-8/1/2 30-Nov-2011 62HAL99 3008308044 Tc Bentfield Bv Netherlands
 
595-4847429-1/1/1 01-Nov-2011 62HIS99 3009138577 Fermentek Israel
 
112-4537044-5/1/1/A 25-Nov-2011 62IBR99 3009188306 MIGHTY PRODUCTS LTD. Nigeria
 
112-4667478-7/1/1 15-Nov-2011 62JAR09 3005200199 Su Zhou Vitajoy BioTech China
 
112-4586106-2/1/1 17-Nov-2011 62JCA11 3009188907 Goedecke Ag Germany
 
112-4540644-7/1/2 08-Nov-2011 62JCC13 3003637173 Pfizer Italia S.p.A Italy
 
M21-0744666-0/5/1 23-Nov-2011 62KAE10 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
M21-0744763-5/2/1 28-Nov-2011 62KAE10 3008367099 Shanghai Trifecta Pharma Ltd. China
 
M21-0744768-4/1/1 28-Nov-2011 62KAE10 3004167039 Alkem Laboratories Ltd. India
 
112-4181608-6/1/2 25-Nov-2011 62KCA01 3006197803 Hecho En Mexico Por Mexico
 
112-4181608-6/1/3 25-Nov-2011 62KCA10 3006197803 Hecho En Mexico Por Mexico
 
112-9123806-4/1/1 02-Nov-2011 62KCR10 3004611844 Exim Pharm International India
 
112-3723442-7/1/1 10-Nov-2011 62KQY10 3009109484 Abler Inc Vanuatu
 
112-9767763-8/1/1 03-Nov-2011 62LAA99 3007953099 Zimbabwe Pharmaceuticals Pvt South Africa
 
UPS-3656052-8/1/1 30-Nov-2011 62LBL47 3003446831 Fludan Fine Chemicals Inc Canada
 
427-7323858-1/6/3 21-Nov-2011 62MBJ99 3005164825 Sato Pharmaceutical Co.,Ltd. Japan
 
112-3746405-7/1/1 08-Nov-2011 62MBL99 3009092690 Zymetech Iceland
 
MA7-0689310-8/6/56 17-Nov-2011 62OAY24 3004567236 Carnival Cruise Lines Bahamas
 
MA7-0689310-8/6/35 17-Nov-2011 62OAY39 3004567236 Carnival Cruise Lines Bahamas
 
MA7-0689310-8/6/43 17-Nov-2011 62OAY47 3004567236 Carnival Cruise Lines Bahamas
 
M21-0744821-1/1/1 03-Nov-2011 62OCA14 3007135407 J P N Pharma Pvt Ltd India
 
M21-0744755-1/1/1 28-Nov-2011 62OCB05 3006094247 Research Pharmaceutical Co Ltd China
 
112-4695860-2/1/1 03-Nov-2011 62OCP05 3005314505 Sandoz International Gmbh Germany
 
112-9732553-5/1/1 02-Nov-2011 62ODA14 3007946957 Eurodrug Labroatories Hong Kong SAR
 
112-9732553-5/1/2 02-Nov-2011 62ODA14 3007946956 Eurodrug Hong Kong SAR
 
112-9732553-5/3/1 02-Nov-2011 62ODA28 3004941693 Ratiopharm Arneimittel Vertriebs Austria
 
112-9732553-5/2/3 02-Nov-2011 62ODA41 3004562307 Sidmark Laboratories India
 
UPS-4040269-1/1/1 08-Nov-2011 62TCY07 3009179005 Peter Gulow Germany
 
AM4-0215605-4/3/1 09-Nov-2011 62UAY99 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
AM4-0215605-4/3/2 09-Nov-2011 62UAY99 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
AM4-0215605-4/3/3 09-Nov-2011 62UAY99 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
AM4-0215605-4/3/4 09-Nov-2011 62UAY99 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
185-0056212-1/34/1 28-Nov-2011 62UBJ99 3002108159 Aayu Impex India
 
185-0056212-1/35/1 28-Nov-2011 62UBJ99 3002108159 Aayu Impex India
 
112-4695860-2/2/1 03-Nov-2011 62UCP08 3003976871 Acterna Uk Ltd United Kingdom
 
112-9491050-3/1/1 02-Nov-2011 62VAA99 3002807086 GlaxoSmithKline Inc. Canada
 
MA7-0689310-8/6/39 17-Nov-2011 62VAY01 3004567236 Carnival Cruise Lines Bahamas
 
UPS-4222149-5/1/1 23-Nov-2011 62VBJ99 3008782479 Chen Naturals Inc Canada
 
M21-0744632-2/9/1 23-Nov-2011 62VCA18 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
112-1895992-5/1/1 02-Nov-2011 62VCA24 3006212620 Bristol-Myers Squibb Pharmaceuti United Kingdom
 
112-9744784-3/1/1 16-Nov-2011 62VIA99 3000264888 Patheon Inc. - Toronto Region Operations Canada
 
100-9022495-6/1/1 02-Nov-2011 62VIL40 1000463698 Nagase & Company Ltd Japan
 
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