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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 60-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
MA7-0689624-2/1/4 23-Dec-2011 60CBY04 3004567236 Carnival Cruise Lines Bahamas
 
MA7-0689624-2/1/3 23-Dec-2011 60CBY04 3004567236 Carnival Cruise Lines Bahamas
 
MA7-0689624-2/1/5 23-Dec-2011 60CBY04 3004567236 Carnival Cruise Lines Bahamas
 
MA7-0689624-2/1/8 23-Dec-2011 60CBY04 3004567236 Carnival Cruise Lines Bahamas
 
112-3825881-3/3/1 28-Dec-2011 60CDA49 3003699941 Cipla Ltd India
 
112-5596693-3/1/2 13-Dec-2011 60CDK48 3008102775 Jageswari Medicine Store India
 
112-1719361-9/1/1 12-Dec-2011 60CDQ46 3004001417 Sato Pharmaceutical Co., Ltd. Taiwan
 
112-4838371-8/3/1/A 09-Dec-2011 60LAA01 3003724366 GlaxoSmithKline Panama S.A. Panama
 
KM6-0054474-6/2/1 13-Dec-2011 60LBJ99 3006262601 Proctor & Gamble Home Products India
 
KM6-0054474-6/2/2 13-Dec-2011 60LBJ99 3006262601 Proctor & Gamble Home Products India
 
805-0123864-8/115/1 15-Dec-2011 60LBJ99 1000564545 Indian Ocean Export Co (Pty) Ltd/(Edms) Bpk South Africa
 
D03-0222964-2/1/1/A 05-Dec-2011 60LBL99 3002955163 Leo Desilets maitre herboriste Canada
 
D03-0222964-2/1/1/B 05-Dec-2011 60LBL99 3002955163 Leo Desilets maitre herboriste Canada
 
D03-0222964-2/1/1/C 05-Dec-2011 60LBL99 3002955163 Leo Desilets maitre herboriste Canada
 
D03-0222964-2/1/1/D 05-Dec-2011 60LBL99 3002955163 Leo Desilets maitre herboriste Canada
 
KM6-0120197-3/29/1 21-Dec-2011 60LBO99 3009212107 Glaxo Smith Kline India
 
KM6-0120197-3/29/2 21-Dec-2011 60LBO99 3009212107 Glaxo Smith Kline India
 
M21-0744925-0/1/1 04-Dec-2011 60LCA01 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-3890890-4/1/1 28-Dec-2011 60LCA14 3004439053 Novartis De Venezuela S.A. Venezuela
 
334-1758590-9/1/1 23-Dec-2011 60LCB65 3008534861 Raks Pharma Pvt Ltd India
 
112-7799179-4/2/5 30-Dec-2011 60LCB69 3004088394 Pfizer India
 
112-3388616-2/2/1 07-Dec-2011 60LCB82 3005968673 Sanofi Aventis De Mexico Sa De Mexico
 
XXX-0278848-8/1/2 22-Dec-2011 60LCY69 3008087129 Genfar Colombia
 
XXX-0176512-3/1/1 14-Dec-2011 60LDL07 3004679500 International Pharmaceuticals, Inc. Philippines
 
112-9775674-8/1/1 28-Dec-2011 60LIA83 2245314 Catalent Pharma Solutions United States
 
PDR-0008450-5/1/1 12-Dec-2011 60LIY75 3004273567 SHREE BALAJI AROMATICS PVT. LTD. India
 
112-5596101-7/1/3 13-Dec-2011 60LIY99 3002808500 Wockhardt, Ltd. India
 
112-5397331-1/2/1 13-Dec-2011 60MCY04 3004075481 Ratiopharm Canada
 
112-1963980-9/1/1 12-Dec-2011 60NPB09 3004367313 Operadora Dawvet, S.A. Mexico
 
002-4188261-2/1/1 16-Dec-2011 60QAS40 3003200255 Gufic Bioscience Limited India
 
MA7-0689624-2/1/6 23-Dec-2011 60QAY07 3004567236 Carnival Cruise Lines Bahamas
 
MA7-0689624-2/1/18 23-Dec-2011 60QAY82 3004567236 Carnival Cruise Lines Bahamas
 
MA7-0689624-2/1/27 23-Dec-2011 60QAY99 3004567236 Carnival Cruise Lines Bahamas
 
UPS-4308316-7/1/1/A 01-Dec-2011 60QBO07 3009114710 Dr Numb China
 
UPS-4308316-7/1/1/B 01-Dec-2011 60QBO07 3009114710 Dr Numb China
 
112-3405149-3/1/1 07-Dec-2011 60QCB07 3005047667 Astra Zeneca S.A. de C.V. Mexico
 
112-9734036-0/1/1 27-Dec-2011 60QCJ56 3008619523 Lne Spain
 
112-3406340-7/1/5 07-Dec-2011 60QCY07 3001743983 Novartis Farmaceutica S.A. De C.V. Mexico
 
UPS-4274265-6/1/1 01-Dec-2011 60QCY46 3009213167 Special Rate - Ups Ph Philippines
 
112-3406340-7/1/3 07-Dec-2011 60QDY07 3005047667 Astra Zeneca S.A. de C.V. Mexico
 
M21-0744989-6/1/1 04-Dec-2011 60SAE27 3005144955 Chemo S.A. Lugano Branch Switzerland
 
MA7-0689624-2/1/1 23-Dec-2011 60SAY23 3004567236 Carnival Cruise Lines Bahamas
 
KM6-0120197-3/25/1 21-Dec-2011 60SBR99 3009212109 Glaxo Smith Kline India
 
KM6-0120197-3/25/2 21-Dec-2011 60SBR99 3009212109 Glaxo Smith Kline India
 
KM6-0120197-3/25/3 21-Dec-2011 60SBR99 3009212109 Glaxo Smith Kline India
 
112-0323231-4/1/1 28-Dec-2011 60SCL25 3004150733 Glaxo Smith Kline Germany
 
112-3825881-3/2/1 28-Dec-2011 60SDA25 3002806711 Cadila Pharmaceuticals Limited India
 
112-4154881-0/2/1 27-Dec-2011 60SDA27 3002307574 Janssen-Ortho Canada
 
112-4154881-0/2/2 27-Dec-2011 60SDA27 3002307574 Janssen-Ortho Canada
 
112-4154881-0/2/5 27-Dec-2011 60SDA27 3006546214 Ranbary Pharmaceut Canada
 
112-4154881-0/2/6 27-Dec-2011 60SDA27 3006546214 Ranbary Pharmaceut Canada
 
112-5596451-6/1/5 13-Dec-2011 60SIY22 3008102815 Rakesh Dutt India
 
112-5596101-7/1/2 13-Dec-2011 60SIY25 3000146207 Glaxo India India
 
UPS-4220249-5/1/5 01-Dec-2011 60TCY05 3009206626 Yeongjung Kim Korea, Republic Of (South)
 
112-5579375-8/2/1 13-Dec-2011 60WAA01 3004362667 Glaxosmithkline Mexico
 
112-5579375-8/2/2 13-Dec-2011 60WBL01 3004362667 Glaxosmithkline Mexico
 
112-5579375-8/1/1/B 13-Dec-2011 60WCA01 3003597306 Glaxosmithkline Mexico, S.A. De C.V. Mexico
 
M21-0745029-0/1/1 28-Dec-2011 60WCA01 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-6323537-9/1/1/C 27-Dec-2011 60WCA16 3004553399 Janssen Cilag United Kingdom
 
XXX-0176508-1/1/1 14-Dec-2011 60WCE16 3001056209 unknown India
 
112-8460973-5/4/1 13-Dec-2011 60WCJ31 3007719665 Diamond Drugs Limited Nigeria
 
112-5579375-8/1/1/C 13-Dec-2011 60WCK01 3003597306 Glaxosmithkline Mexico, S.A. De C.V. Mexico
 
112-6323537-9/1/1/B 27-Dec-2011 60WCK01 3006089866 Smithkline Beecham India India
 
AEK-0020858-3/1/3 23-Dec-2011 60XCA17 3009284965 Ammad Anjum Canada
 
M21-0745031-6/3/1 04-Dec-2011 60XCS17 3005144955 Chemo S.A. Lugano Branch Switzerland
 
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