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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
ED5-0044468-9/6/2/C 19-Apr-2012 61BDC02 3002808091 Bayer Weimar GmbH und Co. KG Germany
XXX-0177611-8/1/2 09-Apr-2012 61E09 3007611307 Cipla India
112-2901731-9/1/1 26-Apr-2012 61FCH14 3008757171 Meditec Tunisia
112-6836679-1/1/5 30-Apr-2012 61GCA57 3008094605 Lloyd Laboratories Inc. Philippines
ARM-0062531-5/219/1 23-Apr-2012 61HAL99 3003615307 Eminence Organic Skin Care Inc. Canada
BTU-0207988-5/1/1 06-Apr-2012 61HBJ05 3008782567 Orion Sales Ltd. Jamaica
EKL-1001049-2/2/1 10-Apr-2012 61HQS03 3003941038 Shouguang Fukang Pharmaceutical Co., Ltd. China
XXX-0177610-9/1/1 09-Apr-2012 61J14 3007361121 Solrex Pharmaceutical Company India
XXX-0177611-8/1/1 09-Apr-2012 61J16 3008153792 Ranbaxy Labs India
AEK-8399157-6/1/1 19-Apr-2012 61JAC08 3009455201 Arour Biotech India
112-6836679-1/1/1 30-Apr-2012 61JCA14 3009460761 New Myrex Laboratory Inc Philippines
112-6836679-1/1/3 30-Apr-2012 61JCA14 3009460761 New Myrex Laboratory Inc Philippines
112-6447466-4/1/2 25-Apr-2012 61JDA08 3005214459 Ranbaxy Pharmaceut Canada
112-6447466-4/1/1 25-Apr-2012 61JDA09 3002653619 Fournier Pharma Inc Canada
112-6697821-7/1/1 05-Apr-2012 61KCA52 3005125301 Reliance Formulation Pvt.Ltd India
E7E-1026048-2/4/11 06-Apr-2012 61KDL27 3003687826 PBM Products, LLC United States
BGX-1091340-4/1/1 18-Apr-2012 61LBY99 3000256561 Weimer Pharma Gmbh Germany
AEK-8396702-2/1/1 16-Apr-2012 61LCK29 3009412069 Channa Fronman Israel
112-7083834-0/1/2 27-Apr-2012 61LCL40 3003228982 Alcon Canada Inc Canada
XXX-0177611-8/1/6 09-Apr-2012 61M38 3005029956 Torrent Pharmaceuticals Limited India
112-6893740-1/1/1 25-Apr-2012 61MCA06 3009468432 Roche Farma Dominican Republic
112-6666889-1/1/1 25-Apr-2012 61MCF99 3004258294 BIOCODEX (HQ) France
112-6666889-1/1/2 25-Apr-2012 61MCF99 3004258294 BIOCODEX (HQ) France
XXX-0282476-2/1/1 16-Apr-2012 61MCY30 3005216832 Abbott Laboratoreis Argentina S.A. Argentina
112-6695646-0/1/1 05-Apr-2012 61MCY99 3003346516 Biocodes France
E7E-1026048-2/4/15 06-Apr-2012 61MDK11 3005579246 Hospira Inc. United States
AEK-8399157-6/2/1 19-Apr-2012 61NCA03 3009455201 Arour Biotech India
112-2908858-3/1/1 26-Apr-2012 61NCA03 3004875395 Laboratorio Psicofarma Sa De Cv Mexico
112-7083834-0/1/1 27-Apr-2012 61NCA83 3007494943 Lundbeck Canada In Canada
112-6757065-8/1/1 30-Apr-2012 61NCB78 3008334958 Pfizer United States
112-8542550-4/1/1 06-Apr-2012 61NCF78 3003668079 Pfizer Sa De Cv Mexico
AEK-8399157-6/1/2 19-Apr-2012 61PCA26 3009455201 Arour Biotech India
XXX-0281671-9/1/2 02-Apr-2012 61PCY17 3006327424 Eli Lilly and Company, Pharmaceutical Delivery United States
E7E-1026048-2/4/6 06-Apr-2012 61PDK58 3009291254 Eli Lily United States
112-6413318-7/1/1 13-Apr-2012 61PIH99 3009438490 Health Herbal Products Pvt. Ltd. India
E7E-1026048-2/4/9 06-Apr-2012 61TDM17 2127022 Perrigo Company United States
112-6878986-9/1/1 25-Apr-2012 61UCB05 3009466111 Astrazeneca Israel
E7E-1026048-2/4/1 06-Apr-2012 61WBJ18 3009420795 Actavis United States
XXX-0281695-8/1/1 02-Apr-2012 61XCY45 3005023799 UCB Farchim SA Switzerland
E7E-1026048-2/4/14 06-Apr-2012 61XDK18 1000162258 Baxter International Inc United States