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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
112-7761274-8/1/1 19-Jun-2012 62ADL05 3008313478 Novartis Health Care Pvt Ltd. India
 
112-0309453-2/1/1 01-Jun-2012 62CDA65 3010418451 Tjoapack Netherlands BV Netherlands
 
112-9648810-3/2/1 01-Jun-2012 62CDJ41 3005466252 Glenmark Pharmaceuticals LTD India
 
112-2073671-9/1/1 04-Jun-2012 62CIZ99 3007785633 Hetero Labs Ltd India
 
112-5536967-4/1/1 20-Jun-2012 62DCB02 2026154 Amgen, Inc. United States
 
E6T-1002066-6/2/1 29-Jun-2012 62FAK23 3006403682 Jiangsu Province Jianerkang Medical Dressing Co. China
 
E6T-1002066-6/2/2 29-Jun-2012 62FAK23 3006403682 Jiangsu Province Jianerkang Medical Dressing Co. China
 
E6T-1002066-6/2/3 29-Jun-2012 62FAK23 3006403682 Jiangsu Province Jianerkang Medical Dressing Co. China
 
E6T-1002061-7/1/1 28-Jun-2012 62FBK34 3006403682 Jiangsu Province Jianerkang Medical Dressing Co. China
 
WC1-8511435-0/1/1 19-Jun-2012 62FBL99 3002600322 Laboratorios Jaloma S.A. de C.V. Mexico
 
KM6-0122130-2/13/1 11-Jun-2012 62FBO20 3008459891 Pankaj Exports India
 
112-7507365-3/1/4 29-Jun-2012 62FDY38 3009533323 Tangherlini Rosa Italy
 
112-7256692-3/1/2 11-Jun-2012 62GAA92 3005548776 Laboratoires Theramex France
 
112-7773190-1/1/1 11-Jun-2012 62GAL99 3004628290 L'Oreal France
 
U47-0490915-7/6/1 01-Jun-2012 62GBO90 3009009153 Menarini Manufakturing Logistics An Italy
 
112-7520037-1/1/1/A 29-Jun-2012 62GCA41 3002871439 Genetica Laboratorios Mexico
 
112-9655341-9/1/3 01-Jun-2012 62GCB46 3005576019 Dompe Farmaceutici Spa Italy
 
XXX-0286443-8/1/5 19-Jun-2012 62GCF90 3008270707 Unipharm S.A. Guatemala
 
XXX-0286429-7/1/3 15-Jun-2012 62GCK46 3008165484 Sanofi Aventis Colombia
 
112-0200755-0/1/2 07-Jun-2012 62GCP49 3008349307 Delpharm Tours France
 
112-0200755-0/1/1 07-Jun-2012 62GCP49 3008349307 Delpharm Tours France
 
XXX-0238624-2/1/2 25-Jun-2012 62GDY18 3004465878 Merck Mexico
 
112-7455321-7/1/1 20-Jun-2012 62ICA29 3004603791 GlaxoSmithKline Spain
 
112-7463092-4/1/2 18-Jun-2012 62KAA10 3007692005 Boehringer Ingelheim Pharma GMBH & Co Germany
 
112-6053842-0/1/1 18-Jun-2012 62KAA10 3008189380 Triveni Chemicals India
 
112-6002645-9/3/2 20-Jun-2012 62KAK08 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/3/1 20-Jun-2012 62KAK08 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6659193-6/1/1 19-Jun-2012 62KCB10 3003596046 Astrazeneca, S.A. De C.V. Mexico
 
XXX-0178032-0/1/1 01-Jun-2012 62KRY10 3009534319 Summit Veterinary Pharmacy Inc. Canada
 
112-5858533-5/1/1 15-Jun-2012 62LCA40 3005968673 Sanofi Aventis De Mexico Sa De Mexico
 
112-6851042-1/1/1 20-Jun-2012 62LCA99 3008297114 Beining Novartis Pharma Co Ltd China
 
112-5582560-0/1/1 19-Jun-2012 62LCS23 3002807297 Ipca Laboratories, Ltd. India
 
U10-5120350-7/25/1 29-Jun-2012 62MBJ01 3008986440 SHWE Hintar Co. Thailand
 
U10-5120350-7/26/1 29-Jun-2012 62MBJ01 3008986440 SHWE Hintar Co. Thailand
 
112-3116179-0/2/1 04-Jun-2012 62MBY08 3003698810 G.R. Lane Health Products Ltd. United Kingdom
 
U33-0023525-6/1/1/A 13-Jun-2012 62MCY08 3004291925 Cadbury Stani Adams Argentina S.A. Argentina
 
U33-0023525-6/1/1/B 13-Jun-2012 62MCY08 3004291925 Cadbury Stani Adams Argentina S.A. Argentina
 
KM6-0057573-2/18/1 21-Jun-2012 62MDJ08 3009543187 Siam Moei Co., Ltd Thailand
 
112-5382029-8/1/1 18-Jun-2012 62MDO01 3002599023 Merck Kgaa Germany
 
112-5762044-7/1/3 20-Jun-2012 62OAB13 3008139706 Labs Gen Far Colombia
 
112-0014806-7/2/1 07-Jun-2012 62OAY14 3008657798 Quest Pharmaceuticals Ltd Nepal
 
112-0014806-7/1/1 07-Jun-2012 62OAY41 3008657797 Sun Phurma Sikkim India
 
112-7129690-1/1/3 11-Jun-2012 62OCA09 3001645453 Boehringer Ingelheim Canada Canada
 
112-7509309-9/1/1/B 29-Jun-2012 62OCA15 2517175 Teva Pharmaceuticals USA, Inc. United States
 
112-5833849-5/2/2 15-Jun-2012 62OCA28 3007243153 Sandoz Div Novartis Farmacuetic Mexico
 
112-7883449-8/1/2 11-Jun-2012 62OCB09 3006407810 Glenmarle Pharmaceticals India
 
112-7500186-0/1/1/C 29-Jun-2012 62OCC24 3004865210 Glaxosmithkline Egypt
 
112-5902323-6/1/1 19-Jun-2012 62OCS26 3008164294 Bdr Pharmaceuticals Int India
 
112-6189648-8/1/1 18-Jun-2012 62OCY26 3003611837 Laboratories Merck Sharp & Dohme France
 
112-6029085-8/1/1 01-Jun-2012 62ODA41 3009352455 Ana Laura Gutrerrez Mexico
 
112-6871058-3/1/1 11-Jun-2012 62ODB44 3002906944 Apotex Inc. Canada
 
112-9314537-5/1/1 07-Jun-2012 62ODE24 1913298 Sanofi - Aventis US LLC United States
 
112-7500186-0/1/1/F 29-Jun-2012 62ODK26 3004758118 Merck & Co Inc United States
 
112-7500186-0/1/1/G 29-Jun-2012 62ODK26 3004758118 Merck & Co Inc United States
 
112-7305528-9/1/1/B 18-Jun-2012 62SCJ03 3002751295 Eureka Medical Clinic British Virgin Islands
 
112-7456058-5/9/1/E 12-Jun-2012 62SDY99 3008132860 Silky Pleasure Cosmetic France
 
D52-0597672-8/1/1 27-Jun-2012 62TCA06 1000288560 Central Pharmacy United Kingdom
 
112-8708629-6/1/3 07-Jun-2012 62TCB07 3008503792 Rx R Us Pharmacy Canada
 
112-6989956-7/1/3 19-Jun-2012 62TDB07 3004393730 Pfizer, Inc. United States
 
112-6002645-9/2/5 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/1/1 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/6 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/8 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/19 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/16 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/11 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/18 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/15 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/10 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/9 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/4 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/3 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/13 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/14 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/7 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/12 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/17 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/2 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
112-6002645-9/2/1 20-Jun-2012 62UAK11 3008177641 Farmacia Homeopathica Vida Mexico
 
KR3-0114728-5/6/1 22-Jun-2012 62UBY99 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
KR3-0114728-5/6/2 22-Jun-2012 62UBY99 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
112-7509024-4/2/1 29-Jun-2012 62UCY99 3002616705 Novartis Consumer Health Canada, Inc. Canada
 
112-6970905-5/1/1 18-Jun-2012 62UDA08 3008310124 Debra Sweeting United States
 
112-5899859-4/1/1 19-Jun-2012 62UDA08 3001804387 Vita Health Products Inc. Canada
 
112-7520632-9/1/1/C 29-Jun-2012 62VAA18 3008011858 Mavi Farmaceutica Sa De Cv Mexico
 
112-0298617-5/1/1 07-Jun-2012 62VAJ99 3004432739 Imres Netherlands
 
112-7520632-9/1/1/A 29-Jun-2012 62VAO18 3004553065 Liferpal MD, S.A. De C.V. Mexico
 
112-3348589-0/1/1 04-Jun-2012 62VCE45 3003795116 Roche Instrument Center AG Switzerland
 
UPS-6609450-5/1/1 28-Jun-2012 62VCH37 3009574700 Sandra Bowen And Associates Canada
 
UPS-6609450-5/1/3 28-Jun-2012 62VCH53 3009574700 Sandra Bowen And Associates Canada
 
KH5-0075104-6/1/1 28-Jun-2012 62VCS12 3002806598 Bidachem S.p.A. Italy
 
112-5833849-5/2/1 15-Jun-2012 62VCS99 3007180551 Bioresearch De Mexico Sa Mexico
 
UPS-6609450-5/1/2 28-Jun-2012 62VDA17 3009574700 Sandra Bowen And Associates Canada
 
AEK-0208512-0/1/1 15-Jun-2012 62VIY31 3009552183 Industrial Formacuetica Cantabria Sa Spain
 
112-2814529-3/1/1 04-Jun-2012 62WBJ09 3004717968 Forest Tosara Ltd. Ireland
 
112-7185729-8/1/1 08-Jun-2012 62WBL99 3008334740 Laboratorie Odysud Sas France
 
BRQ-0102788-8/1/4 22-Jun-2012 62WBY17 2000010864 Cosbel S.A. de C.V. Mexico
 
BRQ-0102788-8/1/3 22-Jun-2012 62WBY17 2000010864 Cosbel S.A. de C.V. Mexico
 
BRQ-0102788-8/1/2 22-Jun-2012 62WBY17 2000010864 Cosbel S.A. de C.V. Mexico
 
BRQ-0102788-8/1/1 22-Jun-2012 62WBY17 2000010864 Cosbel S.A. de C.V. Mexico
 
XXX-0286429-7/1/2 15-Jun-2012 62YCB07 3005783926 Gonher Farmaceutica Colombia
 
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