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
China 916-1825404-8 1 1 Guangzhou Pharmaceutical Imp Exp Corp Guangzhou Guangdong, CN PHI-DO 66BAR99 METHSCOPOLAMINE NITRATE CAS#: 6106-46-3 30-SEP-2008 DIRECTIONS Dominican Republic AA8-0016692-5 28 1 Laboratorios Rangel C. Por A. La Vega , DO PHI-DO 66FBL99 PINK HONEY 19-SEP-2008 UNAPPROVED Israel 112-4214559-0 1 1 Foamix Ltd Rehovot , IL NOL-DO 66GIS20 862023792505 PRESSURIZED VAGINAL FOAM 19-SEP-2008 UNAPPROVED Canada AEK-9533847-7 1 3 Rose Janzen Tillsonburg ON, CA N4G3A2 CIN-DO 66JCA01 SYNTHROID 0.2MG 02-SEP-2008 UNAPPROVED Egypt 112-4018696-8 1 8 Egyptian International Pharmaceutical Industries Co Cairo , EG NOL-DO 66MDA76 662411747879 LIBRAX 2.5MG 10-SEP-2008 UNAPPROVED United Kingdom 112-3982033-8 1 1 Zelens London , GB N176YD NOL-DO 66PBJ99 865111032770 COSMETICS DAY CREAM 10-SEP-2008 NOT LISTED China EB5-0041072-6 2 1 Xi'an Maxsun Bio&Tech Co., Ltd Xi'an CN-61, CN 710000 NYK-DO 66SAS40 D PINITOL 24-SEP-2008 DIRECTIONS China XXX-0840596-2 1 1 Guangzhou Sheenzi Export & Import Trading Co., Ltd. Baiyun District Guanghzhou, CN 510440 LOS-DO 66V--99 Bamboo Cleansing Detox Foot Pads 30-SEP-2008 NOT LISTED FALSE Dominican Republic AA8-0016692-5 2 1 Laboratorios Rangel C. Por A. La Vega , DO PHI-DO 66VAL99 CASTOR OIL 19-SEP-2008 DIRECTIONS Dominican Republic AA8-0016692-5 3 1 Laboratorios Rangel C. Por A. La Vega , DO PHI-DO 66VAL99 POLAR BEAR OIL 19-SEP-2008 DIRECTIONS Dominican Republic AA8-0016692-5 9 1 Laboratorios Rangel C. Por A. La Vega , DO PHI-DO 66VAL99 POLAR BEAR OIL 19-SEP-2008 DIRECTIONS Dominican Republic AA8-0016692-5 12 1 Laboratorios Rangel C. Por A. La Vega , DO PHI-DO 66VAL99 BERGAMOTA OIL 19-SEP-2008 UNSAFE COL United Kingdom AEK-9547880-2 2 5 Fenton Pharmaceuticals Limited London , GB CIN-DO 66VAY99 INDOOR TANNING GEL 09-SEP-2008 NOT LISTED China AEK-9555797-7 1 1 Thermo Electron Sl Alcobendas Madrid , ES CIN-DO 66VAY99 COSMETIC PRODUCTS HERBAL HIAR CREAM 12-SEP-2008 NOT LISTED UNAPPROVED Indonesia AEK-9559273-5 1 1 Pt Media Karya Etam Tangerang Banten , ID 15323 CIN-DO 66VAY99 MITRAGYNA DRIED LEAVES FOR USE IN INCENSE 23-SEP-2008 UNAPPROVED Netherlands UPS-2013134-6 1 1 Bioclin Delft , NL 2628XJ PHI-DO 66VBJ99 MULTIGYN LIQUIGEL MOISTURIZER 11-SEP-2008 UNAPPROVED Mexico UPS-2237635-2 1 10 Pak Logistic Naucalpan Edo , MX CIN-DO 66VBJ99 MICONAZOL CREAM, NO RX, NO ID, PER USE 19-SEP-2008 UNAPPROVED Mexico UPS-2237635-2 1 11 Pak Logistic Naucalpan Edo , MX CIN-DO 66VBJ99 HIDROCORTISONA, NO RX, NO ID,PER USE 19-SEP-2008 UNAPPROVED India DY2-0034818-2 1 1 A Herbo Foundation Guwahati , IN 781021 SWI-DO 66VBJ99 CREAM 29-SEP-2008 DIRECTIONS India DY2-0034818-2 1 1 B Emami Limited Calcutta WB, IN 700001 SWI-DO 66VBJ99 Skin lightening cream 29-SEP-2008 DIRECTIONS Philippines EE6-1237172-8 1 1 Total Nature's Great Value, Inc. Silang Cavite, PH SEA-DO 66VBL99 BIO ENZYME PLUS FRUIT JUICE 03-SEP-2008 UNAPPROVED China GL5-0835224-9 1 1 BEIJING SENWANGZI NATURAL COSMETICS CO. LTD. BEIJING CN-11, CN 100700 LOS-DO 66VBR99 Hard Drive Sexual Enhancement Capsules 11-SEP-2008 UNAPPROVED Macau 336-6592517-1 1 1 Pacifex Investment Limited Macau , MO LOS-DO 66VBY99 ANGELICA (HERBALS & BOTANICAL TEAS);HUM FD DIETARY SUPPL 1 I 03-SEP-2008 NOT LISTED UNAPPROVED Thailand 277-0119311-5 15 1 Cm Cosmetic Ltd. Khonkaen , TH LOS-DO 66VBY99 MELACARE FACE CREAM 29-SEP-2008 NOT LISTED UNAPPROVED Thailand 277-0119211-7 17 1 Cm Cosmetic Ltd. Khonkaen , TH LOS-DO 66VBY99 FACE CREAM 30-SEP-2008 NOT LISTED UNAPPROVED Mexico UPS-2150886-4 1 1 Bayer De Mexico Sa De Cv Mexico Df FN, MX CIN-DO 66VCA99 MYCOSPOR ONICOSET/NO RX/NO ID/PER USE 10-SEP-2008 UNAPPROVED Mexico UPS-2150886-4 1 3 Merck S.A. Juarezjuarez , MX 53370 CIN-DO 66VCA99 DOLO-NEUROBION FORTE/NO RX/NO ID/PER USE 10-SEP-2008 UNAPPROVED Mexico UPS-2237635-2 1 1 Pak Logistic Naucalpan Edo , MX CIN-DO 66VCA99 CYCLOFEMINA, NO RXM NO ID, PER USE 19-SEP-2008 UNAPPROVED Mexico UPS-2237635-2 1 2 Pak Logistic Naucalpan Edo , MX CIN-DO 66VCA99 AMPICILINA 500M G, NORX, NO IS, PER USE 19-SEP-2008 UNAPPROVED Mexico UPS-2237635-2 1 3 Pak Logistic Naucalpan Edo , MX CIN-DO 66VCA99 DOLIZOL, NO RX, NO ID, PER USE 19-SEP-2008 UNAPPROVED Mexico UPS-2237635-2 1 4 Pak Logistic Naucalpan Edo , MX CIN-DO 66VCA99 DICLOFENACO, NO RX, NO ID, PER USE 19-SEP-2008 UNAPPROVED Mexico UPS-2237635-2 1 5 Pak Logistic Naucalpan Edo , MX CIN-DO 66VCA99 CLARITROMICINA 250MG, NO RX, NO ID, PER USE 19-SEP-2008 UNAPPROVED Mexico UPS-2237635-2 1 6 Pak Logistic Naucalpan Edo , MX CIN-DO 66VCA99 PARACETAMOL 500MG, NO RX, NO ID, PER USE 19-SEP-2008 UNAPPROVED Mexico UPS-2237635-2 1 7 Pak Logistic Naucalpan Edo , MX CIN-DO 66VCA99 ERGOTAMINA Y CAFEINA, NO RX, NO ID , PER USE 19-SEP-2008 UNAPPROVED Mexico UPS-2237635-2 1 8 Pak Logistic Naucalpan Edo , MX CIN-DO 66VCA99 BREGAMIN FC, NO RX, NO ID, PER USE 19-SEP-2008 UNAPPROVED Mexico UPS-2237635-2 1 9 Pak Logistic Naucalpan Edo , MX CIN-DO 66VCA99 CLAVUSER AMOOXILINA 500, NO RX, NO ID, PER USE 19-SEP-2008 UNAPPROVED United States UPS-2337360-6 1 1 Speciosa Specialist Chicago, IL 60642-5449 CIN-DO 66VCL99 ERR/CBP/KRATOM EXTRACT INCENSE OIL 22-SEP-2008 DIRECTIONS Canada 112-4144855-7 1 1 Pharmacie Frayne Montreal QC, CA H3S1Z1 NOL-DO 66VCP99 864291639525/MEDICATION 22-SEP-2008 UNAPPROVED Egypt 112-2047168-7 1 1 Maged Boshra Abdel Meseh Miami , EG NOL-DO 66VCP99 964953177486/MEDICATION 30-SEP-2008 UNAPPROVED United Kingdom AEK-9547880-2 2 1 Fenton Pharmaceuticals Limited London , GB CIN-DO 66VCY99 SUN LOTION 09-SEP-2008 NOT LISTED Germany XXX-0149189-4 1 1 B Steierl-Pharma GmbH Herrsching , DE ATL-DO 66VCY99 (Phytocortal) liquid medicines in glass bottles 09-SEP-2008 NOT LISTED NO ENGLISH Korea, Republic Of (South) XXX-0149189-4 1 1 C Kim Yong Soo Acworth, GA 30101-6218 ATL-DO 66VCY99 Assorted tablet form medicines in 11 zip-loc bags 09-SEP-2008 NOT LISTED NO ENGLISH Germany XXX-0149189-4 1 1 D Orthomed GmbH & Co. KG 40764 Lagenfeld , DE ATL-DO 66VCY99 Paks of powder type medicines(Ortho Molar Probiot), various 09-SEP-2008 NO ENGLISH Germany XXX-0149189-4 1 1 E Arzneimittel 76275 Ettlingen , DE ATL-DO 66VCY99 Various Pellet type medicines(Allium, Avena, Solidago) in gl 09-SEP-2008 NOT LISTED LACKS N/C Korea, Republic Of (South) XXX-0149189-4 1 1 F Kim Yong Soo Acworth, GA 30101-6218 ATL-DO 66VCY99 Apparent cream type medicine in plastic tubes 09-SEP-2008 NOT LISTED LACKS N/C Germany XXX-0149189-4 1 1 H ASTA Medica AG 60314 Frankfurt , DE ATL-DO 66VCY99 Apparent liquid medicine (Kamillosan Konzentrat) in glass bo 09-SEP-2008 NOT LISTED LACKS N/C NO ENGLISH China XXX-0149189-4 1 1 I Guangzhou Jingxiutangpharmaceutical Co Ltd Guangzhou , CN ATL-DO 66VCY99 Apparent liquid medicine in plastic bottles 09-SEP-2008 NOT LISTED LACKS N/C NO ENGLISH Korea, Republic Of (South) XXX-0149189-4 1 1 J Kim Yong Soo Acworth, GA 30101-6218 ATL-DO 66VCY99 Apparent liquid medicine (Conjunctisan A) in plastic 09-SEP-2008 NOT LISTED LACKS N/C NO ENGLISH Germany XXX-0149189-4 1 1 K ISO - Arzneimittel 76275 Ettlingen , DE ATL-DO 66VCY99 Apparent liquid medicine (Umckaloabo) in glass 09-SEP-2008 NOT LISTED LACKS N/C NO ENGLISH Japan XXX-0149189-4 1 1 L Taiho Pharmaceutical Co Tokyo , JP 101 ATL-DO 66VCY99 Apparent liquid medicine (Polycain Solution) in plastic 09-SEP-2008 NOT LISTED LACKS FIRM LACKS N/C Germany XXX-0149189-4 1 1 M Dr. Gustav Klein 77732 Zell Am Harmersbach , DE ATL-DO 66VCY99 Apparent medicine (Prostamed & Uro-Select tablets) in plasti 09-SEP-2008 NOT LISTED LACKS N/C NO ENGLISH Germany XXX-0149189-4 1 1 N Coradol Pharma Gmbh 50933 Koln , DE ATL-DO 66VCY99 Apparent liquid medicine (Coradol) in glass bottles 09-SEP-2008 NOT LISTED LACKS N/C NO ENGLISH Germany XXX-0149189-4 1 1 O Verla Pharm Tutzing , DE 82327 ATL-DO 66VCY99 Apparent patent medicines in paper/plastic containers 09-SEP-2008 NOT LISTED LABELING United Kingdom 112-4350288-0 1 1 Eli Lilly And Company Limited Basingstoke Hants, GB RG212XA NOL-DO 66VCY99 866622507954 ALIMTA 19-SEP-2008 UNAPPROVED France 336-6506904-6 1 1 Goemar Laboratories St Malo Cedex , FR 35403 NYK-DO 66VCY99 TRIAMINIC PURE REMEDIES NATURAL SALINE MIST, NON R/X ISOTONI 30-SEP-2008 NOT LISTED UNAPPROVED Germany 112-3920430-1 1 1 Di Budwig Gmbh & Co Kg Oldenburg , DE 26122 NOL-DO 66VDA99 963505455193 Eldi Oil (Linum Usitissimum, Triticum Vulgare) 05-SEP-2008 DIRECTIONS NO ENGLISH UNAPPROVED Egypt 112-4018696-8 1 1 Novartis Pharma Cairo , EG NOL-DO 66VDA99 662411747879 SPASMO 60MG 10-SEP-2008 UNAPPROVED Egypt 112-4018696-8 1 6 Sigma Pharmaceutical Cairo , EG NOL-DO 66VDA99 662411747879 CONGESTAL 60MG 10-SEP-2008 UNAPPROVED Egypt 112-4018696-8 1 7 Janssen-Cilag Cairo , EG NOL-DO 66VDA99 662411747879 MOTILLIUM 10MG 10-SEP-2008 UNAPPROVED Egypt 112-4466963-9 2 1 Servier Egypt Ciza , EG NYK-DO 66VDA99 980180385580 DAFLON 500MG TABLETS 18-SEP-2008 UNAPPROVED South Africa 112-4291662-8 1 1 Global Nutritional Manufacturers Hehops Parks , ZA NOL-DO 66VDB99 865103605021 PROSLAN 19-SEP-2008 DIRECTIONS LACKS FIRM LABELING UNAPPROVED South Africa 112-4291662-8 1 5 Global Nutritional Manufacturers Hehops Parks , ZA NOL-DO 66VDB99 865103605021 ANENOL 19-SEP-2008 DIRECTIONS LACKS FIRM LACKS N/C DRUG NAME UNAPPROVED South Africa 112-4291662-8 1 4 Global Nutritional Manufacturers Hehops Parks , ZA NOL-DO 66VDB99 865103605021 CADIO 19-SEP-2008 DIRECTIONS LACKS FIRM LACKS N/C DRUG NAME UNAPPROVED South Africa 112-4291662-8 1 3 Global Nutritional Manufacturers Hehops Parks , ZA NOL-DO 66VDB99 865103605021 IMMUNO PLUS 19-SEP-2008 DIRECTIONS LACKS FIRM LACKS N/C DRUG NAME UNAPPROVED South Africa 112-4291662-8 1 2 Global Nutritional Manufacturers Hehops Parks , ZA NOL-DO 66VDB99 865103605021 PHYTOCAL 19-SEP-2008 DIRECTIONS LACKS FIRM LACKS N/C UNAPPROVED Dominica XXX-0156518-4 3 1 Alopecil Corporation , C x A. Santo Domingo R.D , DO SJN-DO 66VDL99 Depurativo Siglo 22 Jarabe 30-SEP-2008 UNAPPROVED Nigeria XXX-0153257-2 2 1 May & Baker Nig, Plc Lagoslagos , NG JOS06 ATL-DO 66VDY99 Loxagyl (Metronidazole BP- 200mg/5ml- 60ml) 09-SEP-2008 NOT LISTED UNAPPROVED Nigeria XXX-0153257-2 2 2 Nigerian-German Chemicals Plc. Ogun State , NG ATL-DO 66VDY99 Benylin with Codeine (100ml) 09-SEP-2008 NOT LISTED UNAPPROVED Nigeria XXX-0153257-2 2 3 Chemo-Pharma Laboratories Limited Lagos , NG ATL-DO 66VDY99 Suphtrim (Co-Trimoxazole Suspension) 50ml 09-SEP-2008 NOT LISTED UNAPPROVED Nigeria XXX-0153257-2 2 4 Copac Nigeria ltd Lagos Ng-La, NG None ATL-DO 66VDY99 Alabukun Powder (Acetylsalicylic Acid- 760mg / Caffeine 60mg 09-SEP-2008 NOT LISTED UNAPPROVED Ireland XXX-0153257-2 2 5 Kensington Pharmaceuticals Ltd. Dublin , IE ATL-DO 66VDY99 Piccan Teething Remedy (100 ml) 09-SEP-2008 NOT LISTED UNAPPROVED France 112-3780528-1 1 3 Laboratoire Glaxo Smith Kline Marly Le Roi , FR 78160 NOL-DO 66VIP99 863648796161 VENTOLINE 03-SEP-2008 UNAPPROVED Ireland 112-4055280-5 1 1 Ivax Ireland Waterford , IE NOL-DO 66VIP99 852864781840 BECLAZONE 50 MG 10-SEP-2008 UNAPPROVED Germany 112-4059596-0 1 1 Essex Pharma Munich , DE NOL-DO 66VIP99 861302495679 DOTRATURE 10MG 11-SEP-2008 UNAPPROVED Canada 112-4166725-5 1 1 Glaxosmithkline Biologicals Laval QUEBEC, CA H7V3S8 NOL-DO 66VIP99 864286040111 NICORETTE INHALER 19-SEP-2008 UNAPPROVED China EJ8-0816444-9 3 1 Minkang Drug Manufactory Yichang , CN SAN-DO 66VJA99 HUANG LIAN TABLET 11-SEP-2008 NOT LISTED NO ENGLISH DRUG NAME United Kingdom AEK-9547880-2 2 2 Fenton Pharmaceuticals Limited London , GB CIN-DO 66VJY99 SUN LOTION 09-SEP-2008 NOT LISTED Canada 112-3995448-3 1 1 Boiron Canada Inc Longueuil QC, CA J4G1T5 NOL-DO 66VNY99 Unknown product in glass vials. 08-SEP-2008 DR QUALITC Germany 112-4217797-3 1 1 Heel Gmbh Baden-Baden , DE NOL-DO 66YAS99 791124860300 Cerium Oxalicum & Manganum Phosphoricum 19-SEP-2008 NOT LISTED UNAPPROVED India AD1-0390518-9 1 1 Shanaz Herbals New Delhi , IN SEA-DO 66YBY99 FAIR ONE FACIAL CREAM 16-SEP-2008 UNAPPROVED Dominican Republic AA8-0016692-5 4 1 Laboratorios Rangel C. Por A. La Vega , DO PHI-DO 66YBY99 SNAKE OIL 19-SEP-2008 DIRECTIONS Dominican Republic AA8-0016692-5 13 1 Laboratorios Rangel C. Por A. La Vega , DO PHI-DO 66YBY99 RICINO OIL 19-SEP-2008 DIRECTIONS UNSAFE COL India 734-0038184-1 1 7 Ayushakti Ayurved Pvt Ltd Mumbai 4000092 , IN NYK-DO 66YCL99 Painmukti Minor Pain Lotion 02-SEP-2008 DIRECTIONS United States 112-4274563-9 1 1 Tolerx Cambridge, MA 02139 NOL-DO 66YIS99 838135826049 TOLERX 19-SEP-2008 UNAPPROVED