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
Colombia AEK-9585679-1 1 1 Universidad De Antioquia Medellin , CO FLA-DO 61AIK09 EMETINE SALT SAMPLE FOR LAB. ONLY 02-SEP-2008 NOT LISTED UNAPPROVED China 144-1813965-8 1 1 Hangzhou Xiaoshan Yongsheng Foreign Trade Co., Ltd Zhejiang , CN 311200 DET-DO 61DKR99 Phenyl Salicylate 23-SEP-2008 NOT LISTED Egypt 112-4018696-8 1 5 Memphis Pharma Cairo , EG NOL-DO 61EDA08 662411747879 CLARITINE 10-SEP-2008 UNAPPROVED China M21-0738332-7 3 1 Wendt-Chemie Vertriebsges Mbh & Co. Hamburg , DE 22041 FLA-DO 61FAB56 CLARITHROMICIN 500MG FOR EXPORT ONLY, PLEASE REFUSE MERCHAND 22-SEP-2008 UNAPPROVED China M21-0738332-7 6 1 Wendt-Chemie Vertriebsges Mbh & Co. Hamburg , DE 22041 FLA-DO 61FAE53 CEFADROXIL MONOHYDRATE FOR EXPORT ONLY (PLEASE REFUSE MERCHA 22-SEP-2008 UNAPPROVED India AEK-9134503-9 1 1 Dr Lall Kolkata , IN NYK-DO 61FCA54 CIFRAN TABLETS 18-SEP-2008 NOT LISTED UNAPPROVED Colombia 112-4257019-3 1 1 Procaps S. A. Bogota , CO NOL-DO 61FCN56 865797632312 CLARITRMICINA 500 MG 19-SEP-2008 UNAPPROVED Canada 112-4157692-8 1 1 Janssen-Ortho North York ON, CA M3C1L9 NOL-DO 61GCY85 864301964540/FLOXIN 22-SEP-2008 UNAPPROVED China M21-0738332-7 4 1 Wendt-Chemie Vertriebsges Mbh & Co. Hamburg , DE 22041 FLA-DO 61HAB43 LEVOFLOXACIN 500MG FOR EXPORT ONLY "PLEASE REFUSE CARGO" 22-SEP-2008 UNAPPROVED Dominican Republic AA8-0016692-5 18 1 Laboratorios Rangel C. Por A. La Vega , DO PHI-DO 61HAL99 METHIOLATE 19-SEP-2008 UNAPPROVED Taiwan AEK-9130821-9 1 1 SCI Pharmtech Inc. Taoyuan , TW 1234 NYK-DO 61JCR04 PROBUCOL 16-SEP-2008 DIRECTIONS India 315-8231985-6 1 1 Ranbaxy Laboratories, Limited Simour District , IN 173 025 PHI-DO 61JCS13 PRAVASTATIN SODIUM,USP/DMF 16031 END USER: OHM LABORATORIE 29-SEP-2008 DRUG GMPS India 315-8231985-6 1 2 Ranbaxy Laboratories, Limited Simour District , IN 173 025 PHI-DO 61JCS13 PRAVASTATIN SODIUM,USP/DMF 16031 END USER: OHM LABORATORIE 29-SEP-2008 DRUG GMPS India 315-8231985-6 1 3 Ranbaxy Laboratories, Limited Simour District , IN 173 025 PHI-DO 61JCS13 PRAVASTATIN SODIUM,USP/DMF 16031 END USER: OHM LABORATORIE 29-SEP-2008 DRUG GMPS India AEK-9134503-9 3 1 Dr Lall Kolkata , IN NYK-DO 61MCA99 MYLORIE TABLETS 18-SEP-2008 NOT LISTED UNAPPROVED India 112-4274837-7 1 1 Aadi Vighnesh Chem Private Ltd. Mumbai , IN NOL-DO 61NAS32 861830971690/IMIPRAMINE HCL 19-SEP-2008 NOT LISTED UNAPPROVED United States 112-2167982-5 1 1 Pfizer Kalamazoo, MI 49001-0101 NOL-DO 61NCB70 865277153528,LITHIUM 300MG 25-SEP-2008 UNAPPROVED Egypt 112-4018696-8 1 2 Sanor Cairo, Egypt , EG NOL-DO 61NDE55 662411747879 DOGMATIL 50MG 10-SEP-2008 UNAPPROVED Canada AEK-9533847-7 1 5 Rose Janzen Tillsonburg ON, CA N4G3A2 CIN-DO 61PCA55 METFORMAN 500MG 02-SEP-2008 UNAPPROVED Canada AEK-9533847-7 1 2 Rose Janzen Tillsonburg ON, CA N4G3A2 CIN-DO 61PCA62 ACTOS 45MG 02-SEP-2008 UNAPPROVED India 231-7068984-1 1 2 Granules India Limited Hyderabad , IN 500 033 NYK-DO 61PCS55 COMPRESSO MF 95P - FOR HUMAN USE 04-SEP-2008 DIRECTIONS Canada AEK-9533847-7 1 11 Rose Janzen Tillsonburg ON, CA N4G3A2 CIN-DO 61PCY54 HUMALOG 02-SEP-2008 UNAPPROVED India XXX-0137804-2 1 2 Franco Indian Phrma Ltd Mumbai , IN ATL-DO 61PDY26 Metformin Tablets I.P. Glyciphage 09-SEP-2008 UNAPPROVED Egypt 112-4018696-8 1 4 Eva Pharama Cairo , EG NOL-DO 61TDA12 662411747879 METOGRAINE 5MG 10-SEP-2008 UNAPPROVED United Kingdom 112-4350288-0 1 3 Amdipharm Essex , GB NOL-DO 61TDY22 866622507954 ANZEMET 19-SEP-2008 UNAPPROVED Germany 112-4140891-6 1 1 Engelhard Arzneimittel Niederdorfelden , DE NOL-DO 61WBO18 863228352353 Mykoderm Cream 19-SEP-2008 UNAPPROVED India ALN-5504553-6 1 1 Cipla Limited Maharashitra , IN 410 220 NYK-DO 61WCS45 FLUCONAZOLE (MICRONIZED) 22-SEP-2008 DIRECTIONS Egypt 112-4018696-8 1 9 Janssen-Cilag Cairo , EG NOL-DO 61XDA09 662411747879 STUGERON 25MG 10-SEP-2008 UNAPPROVED