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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 61-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
761-0072002-8/3/1 06-Apr-2009 61FCA54 3006527496 S.P.M. Corporation Vietnam
 
761-0072002-8/4/1 06-Apr-2009 61FCA54 3006527496 S.P.M. Corporation Vietnam
 
XXX-0218546-1/1/2 24-Apr-2009 61FCA56 3005096307 Laboratorios Stein S.A. Costa Rica
 
112-7030855-7/1/1 24-Apr-2009 61FIY14 3007489076 Esaam El Din Abdelaal Mostafa Egypt
 
112-6890629-7/1/1 09-Apr-2009 61GCY85 3007472478 Shenyang Freeway High-Tech Co., LTD China
 
XXX-0159480-4/1/18 06-Apr-2009 61HBL05 3004737602 Willard Manufacturing Inc. Canada
 
761-0072002-8/5/1 06-Apr-2009 61HCA43 3007339169 Pymepharco Vietnam
 
761-0072002-8/2/1 06-Apr-2009 61JCA14 3006527496 S.P.M. Corporation Vietnam
 
112-7061149-7/1/1 24-Apr-2009 61JCA99 3006972430 Hillside Pharmacy Canada
 
DO7-8211249-7/1/4 23-Apr-2009 61JCB99 3007480327 Maccalid Misquith India
 
DZ1-0386180-0/33/1 14-Apr-2009 61JKA99 3007326071 Gansu Light Inustrial Products Import And Export Corp. Ltd China
 
W33-0990785-3/1/1/B 23-Apr-2009 61LDR08 3005080039 Hebei Changshan Biochemical Pharmaceutical Co., Ltd. China
 
W33-0990785-3/1/1/A 28-Apr-2009 61LDR08 3005080039 Hebei Changshan Biochemical Pharmaceutical Co., Ltd. China
 
W33-0770304-9/1/1/A 28-Apr-2009 61LDR08 3005080039 Hebei Changshan Biochemical Pharmaceutical Co., Ltd. China
 
W33-0770304-9/1/1/B 28-Apr-2009 61LDR08 3005080039 Hebei Changshan Biochemical Pharmaceutical Co., Ltd. China
 
112-7019162-3/2/2 24-Apr-2009 61NAA05 3003899301 Biovail Corporation Canada
 
UPS-4363514-1/2/2 22-Apr-2009 61NCA03 3007488687 Baspac Products Canada
 
112-7043122-7/1/1 24-Apr-2009 61NCE80 3002806439 Pfizer Canada Inc. Canada
 
144-9154675-2/1/1 22-Apr-2009 61NCS03 3002807897 Plantex Ltd. Chemical Industries Israel
 
UPS-4420071-3/1/1 27-Apr-2009 61PCA09 3006688119 Citinetwork India
 
UPS-3792041-8/1/1/B 10-Apr-2009 61PCA55 1017709 Bristol Myers Squibb United States
 
DO7-8211249-7/1/6 23-Apr-2009 61PCB26 3007480327 Maccalid Misquith India
 
112-6884355-7/1/1 17-Apr-2009 61TCZ29 1000192162 Alkaloids Pvt. Ltd. India
 
AEK-9161878-1/1/1 20-Apr-2009 61WCA45 3007411427 Dr Kavita Singh India
 
UPS-4413226-2/1/36 28-Apr-2009 61WCY45 3000203232 Apothecure, Inc United States
 
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