Refusal Actions by FDA as Recorded in OASIS


   Country of Origin                     Entry #   DOC  Line Suffix
   Manufacture Name
   City / Country or region                                 District
   Product Code        Product Description
                          Date                              Reason
United States 224-0360975-7 1 2 Hospira, Inc. Abbott Park, IL 60064-3503 CHI-DO 60CCP04 EPINEHRINE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY 04-AUG-2008 NOT LISTED UNAPPROVED United States 224-0360975-7 1 10 Hospira, Inc. Abbott Park, IL 60064-3503 CHI-DO 60CCP04 EPINEHRINE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY 04-AUG-2008 NOT LISTED UNAPPROVED India 312-0248105-2 3 1 Sami Chemicals & Extracts Ltd., Bangalore , IN 560 058 NYK-DO 60DBR99 7 KETO DHEA ACETATE 07-AUG-2008 NOT LISTED DIRECTIONS United Kingdom 112-1640058-3 2 1 A The Boots Company Plc Nottingham Ng2 3aa , GB NOL-DO 60LAP99 Panadol (1 and 3) 21-AUG-2008 UNAPPROVED United Kingdom 112-1640058-3 2 1 C The Boots Company Plc Nottingham Ng2 3aa , GB NOL-DO 60LAP99 PRO Namel Daily Toothpaste 21-AUG-2008 NOT LISTED United Kingdom 112-1640058-3 2 1 B The Boots Company Plc Nottingham Ng2 3aa , GB NOL-DO 60LAP99 Paracetamol (2 and 4) 21-AUG-2008 UNAPPROVED Ukraine BQL-0016816-9 5 1 Galafarm Kyiv , UA NYK-DO 60LAY07 CAMPHOR OIL 05-AUG-2008 NOT LISTED UNAPPROVED Nigeria HD8-0089119-8 1 1 E PZ Nigeria Limited Lagos Ng-La, NG None LOS-DO 60LBJ07 Muscle Ache Ointment 05-AUG-2008 NOT LISTED UNAPPROVED India 411-8164487-7 17 1 Makson Industries Pvt. Ltd. Bonthapally , IN SWI-DO 60LBJ99 IODEX 18-AUG-2008 NOT LISTED India 411-8164487-7 14 1 Emami Limited Kolkata , IN 700107 SWI-DO 60LBL99 NAVEATAN OIL 18-AUG-2008 NOT LISTED China FS2-8010611-3 4 5 Xiamen Traditional Chinese Medicine Co., Ltd. Xiamen, Fujian CN-35, CN 361009 NYK-DO 60LBO04 RESTORATIVE TONIC 14-AUG-2008 NOT LISTED France 112-1503714-7 1 1 Laboratoire Glaxosmithkline Cedex , FR 78163 NOL-DO 60LCA86 937012404311 NARAMIG 2.5MG 22-AUG-2008 UNAPPROVED United States EI5-5118464-7 1 1 Amgen Inc Thousand Oaks, CA 91320-1799 NYK-DO 60LCK99 ENBREL 25 (etanercept) 04-AUG-2008 NOT LISTED United States 224-0360975-7 1 5 Medique Products Wood Dale, IL 60191-1204 CHI-DO 60LCP01 ACETAMINOPHEN FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY 04-AUG-2008 NOT LISTED United States UPS-1704055-9 1 8 Phoenix Scientific St . Joseph, MO 64506 CIN-DO 60LLK71 XYLAZINE, VET USE 04-AUG-2008 AGR RX Mexico UPS-1704055-9 1 3 Todo Pak Guadalajara Jal. , MX 44620 CIN-DO 60NCY14 TESTOSTERONA, VET USE 04-AUG-2008 NEW VET DR United States 224-0360975-7 1 11 Hospira, Inc. Abbott Park, IL 60064-3503 CHI-DO 60QCP07 LIDOCAINE FOR UAL MEDICAL KITS FOR INFLIGHT USE ONLY 04-AUG-2008 NOT LISTED UNAPPROVED Israel G32-0130013-1 1 1 Medibrands Ltd Yokeam Elit , IL NYK-DO 60QCY52 VIRACTIN GEL 7.1 G 06-AUG-2008 NOT LISTED UNAPPROVED Israel G32-0130013-1 2 1 Medibrands Ltd Yokeam Elit , IL NYK-DO 60QCY52 VIRACTIN GEL 7.1G 06-AUG-2008 NOT LISTED UNAPPROVED India BGK-0025378-2 7 1 Southern Drugs & Pharmaceuticals& manfactured for GlaxoSmith Punjab , IN DET-DO 60SAR99 ENO (Fruit Salt) 11-AUG-2008 DIRECTIONS INCONSPICU UNAPPROVED South Africa AEK-9683878-0 1 1 World Health Products Lynnwood , ZA LOS-DO 60SBY99 SALINE AND REAGENTS(FORMAL ENTRY REQUESTED BY FDA) 29-AUG-2008 UNAPPROVED Spain 506-0817766-8 1 1 Quimica Sintetica, SA Alcala De Henares, Madrid , ES 28805 NYK-DO 60SCS22 FAMOTIDINE 22-AUG-2008 DIRECTIONS Spain 506-0817766-8 2 1 Quimica Sintetica, SA Alcala De Henares, Madrid , ES 28805 NYK-DO 60SCS22 FAMOTIDINE 22-AUG-2008 DIRECTIONS Spain 506-0817766-8 3 1 Quimica Sintetica, SA Alcala De Henares, Madrid , ES 28805 NYK-DO 60SCS22 FAMOTIDINE 22-AUG-2008 DIRECTIONS Spain 506-0817860-9 1 1 Quimica Sintetica, SA Alcala De Henares, Madrid , ES 28805 NYK-DO 60SCS22 FAMOTIDINE 27-AUG-2008 DIRECTIONS