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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
AEK-0308668-9/1/1 10-Aug-2012 62CAA99 3009641325 Batras Positive Health Clinic India
 
AEK-0308831-3/3/1 10-Aug-2012 62CCA99 3009645958 Jakuv Jankowski United Kingdom
 
112-8945642-3/2/1 15-Aug-2012 62CCA99 3008729011 Emcure Pharmaceuticals India
 
112-8103330-3/1/2 15-Aug-2012 62CCC99 3008980365 Drug International Limited Bangladesh
 
112-8578146-9/1/2 14-Aug-2012 62CDA99 3006441952 CONCORD DRUGS LTD India
 
M21-0745835-0/2/1 21-Aug-2012 62FAA13 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-8273378-6/1/1 07-Aug-2012 62FAR99 3009616737 Oluwakemi Onaddkun Nigeria
 
916-2189404-6/1/1 17-Aug-2012 62FAY23 3008846192 SHANGHAI YINJING INDUSTRY CO., LTD. China
 
916-2189404-6/6/1 17-Aug-2012 62FAY23 3008846192 SHANGHAI YINJING INDUSTRY CO., LTD. China
 
916-2189404-6/7/1 17-Aug-2012 62FAY23 3008846192 SHANGHAI YINJING INDUSTRY CO., LTD. China
 
916-2189404-6/8/1 17-Aug-2012 62FAY23 3008846192 SHANGHAI YINJING INDUSTRY CO., LTD. China
 
916-2189404-6/10/1 17-Aug-2012 62FAY23 3008846192 SHANGHAI YINJING INDUSTRY CO., LTD. China
 
M21-0745849-1/1/1 21-Aug-2012 62GAA46 3007195608 Ciron Drugs & Pharmaceuticals Pvt India
 
112-8306784-6/1/1 07-Aug-2012 62GBK99 3009625506 Shri Marwa India
 
112-8305153-5/1/1 07-Aug-2012 62GBK99 3008855266 Shree Marwal Sevashram India
 
112-8469913-4/1/1 09-Aug-2012 62GBX99 3008855266 Shree Marwal Sevashram India
 
AEK-0310455-7/3/1 22-Aug-2012 62GCA41 3009675885 Dr Rafiq Ahmed (Mbbs Mumbai) India
 
M21-0745849-1/2/1 21-Aug-2012 62GCB94 3007195608 Ciron Drugs & Pharmaceuticals Pvt India
 
XXX-0242924-0/1/11 29-Aug-2012 62GCY18 3005385701 Unipharm (International) S.A. Guatemala
 
XXX-0243010-7/1/14 29-Aug-2012 62GCY18 3005453583 Rich Kwality Products India
 
UPS-7138127-7/1/1 13-Aug-2012 62GCY46 3006296622 Sanofi Aventis De Mexico Sa De Cv Mexico
 
XXX-0242924-0/1/12 29-Aug-2012 62GCY90 3004251330 Laboratorios Francelia Honduras
 
XXX-0243010-7/1/2 29-Aug-2012 62GCY90 3005353047 Unipharm Guatemala C.A. Guatemala
 
XXX-0243010-7/1/33 29-Aug-2012 62GCY90 3004251330 Laboratorios Francelia Honduras
 
M21-0745776-6/5/1 13-Aug-2012 62GDL18 3008367099 Shanghai Trifecta Pharma Ltd. China
 
XXX-0290488-7/1/4 01-Aug-2012 62GDY18 3004641553 Merck, S.A. de C.V. Mexico
 
XXX-0242903-4/1/1 29-Aug-2012 62GDY18 3006347951 Merck Sa De Cv Mexico
 
112-8418433-5/1/1 10-Aug-2012 62ICB30 1018495 Patheon Manufacturing Services, LLC United States
 
XXX-0242908-3/1/1 29-Aug-2012 62ICY81 3005364626 Astra Zeneca Uk Lt United Kingdom
 
112-8727067-7/1/1 01-Aug-2012 62IIA99 3009666411 Pfizer Ltd Canada
 
UPS-4006855-6/1/1 17-Aug-2012 62IIS97 3007255826 BSP Pharmaceuticals Srl Italy
 
M21-0745835-0/4/1 21-Aug-2012 62KAA99 3005144955 Chemo S.A. Lugano Branch Switzerland
 
M21-0746112-3/1/1 21-Aug-2012 62KAE10 3007522260 Lyka Bdr International Ltd India
 
XXX-0242818-4/1/8 27-Aug-2012 62KCY10 3004399994 Laboratorio Franco Colombiano Lafrancol S.A. Colombia
 
XXX-0243010-7/1/32 29-Aug-2012 62KCY11 3007341044 Laboratorios Finlay Honduras
 
988-0233278-7/1/1 31-Aug-2012 62KOR10 3009242499 Guilin Hwasun Pharmaceutical Co Ltd China
 
396-0159989-5/9/1 01-Aug-2012 62MAJ01 3007789391 Taca International Airlines El Salvador
 
112-8278271-8/6/1 10-Aug-2012 62MBJ08 3009617663 Delta Cosmetics United Kingdom
 
AEK-0283388-3/1/1 30-Aug-2012 62MBL08 3009021883 Inverpal Eu Colombia
 
112-8578146-9/1/1 14-Aug-2012 62OAA05 3008367787 Aventis Pharma Limited India
 
M21-0746010-9/1/1 13-Aug-2012 62OBA41 3005144955 Chemo S.A. Lugano Branch Switzerland
 
AEK-0310251-0/1/2 20-Aug-2012 62OCA05 3009671550 Bhairawnath Chs India
 
AEK-0310251-0/1/3 20-Aug-2012 62OCA09 3009671550 Bhairawnath Chs India
 
AEK-0310455-7/2/1 22-Aug-2012 62OCA09 3009675885 Dr Rafiq Ahmed (Mbbs Mumbai) India
 
112-8945642-3/2/2 15-Aug-2012 62OCA41 3004464238 Dr. Reddy's Laboratories Limited India
 
112-8103330-3/1/1 15-Aug-2012 62OCC14 3003670128 Square Pharmaceuticals Inc Bangladesh
 
XXX-0242818-4/1/10 27-Aug-2012 62OCY22 3008226274 Sanofi Aventis Colombia
 
XXX-0242818-4/1/5 27-Aug-2012 62OCY41 3005632939 Laboratories La Sante Colombia
 
XXX-0242818-4/1/7 27-Aug-2012 62OCY41 3006198949 Laboratory Genfar Sa Colombia
 
112-8578146-9/1/5 14-Aug-2012 62ODA09 3009650047 Swiss Garnie Lire Science India
 
112-8369040-7/6/1 03-Aug-2012 62SAL99 3009644793 AL-Afdaliyah Company Global Saudi Arabia
 
112-8146216-3/2/2 07-Aug-2012 62SBY99 3004181110 Skin Sciences Laboratory, Inc. Philippines
 
112-8793439-7/1/1 23-Aug-2012 62TCZ02 3003510514 Hetero Drugs Ltd. - Unit 1 India
 
BKM-0028627-8/10/19 27-Aug-2012 62U99 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
BER-4081171-1/1/1 14-Aug-2012 62UCS01 3002807824 BASF Pharma (Evionnaz) SA Switzerland
 
396-0159989-5/11/1 01-Aug-2012 62WAY99 3007789391 Taca International Airlines El Salvador
 
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