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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 65-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-8112597-3/1/1/B 28-Dec-2011 65FON99 3000162737 Bomac Laboratories Ltd New Zealand
 
112-3825881-3/1/1 28-Dec-2011 65JDA21 3004139310 Elder Pharmaceutical Ltd India
 
112-3781664-5/1/1/B 06-Dec-2011 65JDA39 1000556091 Bayer Mexico S.A. de C.V. Mexico
 
597-0167232-7/1/5 23-Dec-2011 65LB99 3005915537 Umo International Co Ltd Taiwan
 
112-2404742-8/1/1 12-Dec-2011 65LBJ99 3008935133 Body Ship United States
 
112-2404742-8/1/2 12-Dec-2011 65LBJ99 3008935133 Body Ship United States
 
112-2404742-8/1/5 12-Dec-2011 65LBJ99 3008935133 Body Ship United States
 
336-3360148-3/1/2 01-Dec-2011 65LBL11 3003052101 Nidaria Technology, LTD. Israel
 
336-3360148-3/1/4 01-Dec-2011 65LBL99 3003052101 Nidaria Technology, LTD. Israel
 
336-3360148-3/1/3 01-Dec-2011 65LBL99 3003052101 Nidaria Technology, LTD. Israel
 
UPS-4397842-4/1/1 12-Dec-2011 65PAA02 3009229351 Abex Capital Inc. Dominican Republic
 
112-9881946-0/1/1 13-Dec-2011 65PCA02 3004502013 Ethical Pharmaceutical Dominican Republic
 
112-7799179-4/2/6 30-Dec-2011 65PCB02 3004088394 Pfizer India
 
112-3215343-2/1/1 28-Dec-2011 65PDA02 2416101 Pfizer Inc. United States
 
112-2809214-9/1/1 12-Dec-2011 65PDH99 3008983645 Motherland Laboratories India
 
112-8460973-5/3/1 13-Dec-2011 65QAF53 3007719667 Lingbo Dahongying Pharmaceutical Nigeria
 
112-3890890-4/1/2 28-Dec-2011 65QCC24 1000389041 Laboratorios Vargas Sa Venezuela
 
411-8326176-1/1/1 01-Dec-2011 65QCS60 3007931994 Fleming Laboratories Ltd. India
 
UPS-4220249-5/1/2 01-Dec-2011 65QCY01 3009206626 Yeongjung Kim Korea, Republic Of (South)
 
112-4225543-3/1/1 06-Dec-2011 65QOP22 1000429220 Baxter Healthcare Corp United States
 
J89-0116336-2/1/1 02-Dec-2011 65R18 3003637463 SmithKline Beecham SA Spain
 
J89-0116188-7/3/1 07-Dec-2011 65R18 3008095883 Shreeji Masala Products Pvt Ltd India
 
MA7-0689624-2/1/24 23-Dec-2011 65RAY14 3004567236 Carnival Cruise Lines Bahamas
 
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