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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
AFJ-0040214-4/47/1 07-Aug-2008 61FBL21 3003740869 Reckitt Benkiser Ltd United Kingdom
112-1454167-7/1/1 22-Aug-2008 61GAS81 3004146280 Ancheng Pharmaceutical Co China
T77-1052334-3/1/1 05-Aug-2008 61GCS45 1000173675 Katwijk Chemie Bv Netherlands
AEK-9115524-8/1/1 27-Aug-2008 61GCS45 1000173675 Katwijk Chemie Bv Netherlands
EBH-0061991-9/54/1/A 26-Aug-2008 61HBJ05 3003465072 Procter & Gamble Philippine Manufacturing Corp Philippines
M21-0738138-8/1/1 25-Aug-2008 61HDA99 3006623417 Granules India Limited India
112-3878754-6/2/1 14-Aug-2008 61JDC08 3005088016 Godecke Gmbh Germany
224-0360975-7/1/8 04-Aug-2008 61KCP05 2016148 International Medication Systems Limited United States
201-3055796-9/1/1 07-Aug-2008 61KCS22 3004021229 Aurobindo Pharma Ltd India
112-1657516-0/1/1 22-Aug-2008 61LCB13 3006705304 Trilluim Drugmart Canada
224-0360975-7/1/9 04-Aug-2008 61LCP20 3005339463 Hospira, Inc. United States
112-3878754-6/1/1 14-Aug-2008 61LDC38 3002808208 Sanofi Winthrop Industrie France
336-8835721-2/1/1 11-Aug-2008 61LIA99 3005720260 Eli Lilly United States
336-8835721-2/2/1 11-Aug-2008 61LIS99 3003604942 Ube Industries Ltd. Japan
112-3572622-4/1/1 06-Aug-2008 61NBR55 3006983608 Hwasun Biotechniologist Co Ltd China
231-7065032-2/1/2 12-Aug-2008 61PCS55 3003616352 Granules India Limited India
UPS-1755548-1/1/1 21-Aug-2008 61PDB55 3006693316 Speedex Sa Greece
AA8-0016692-5/7/1 27-Aug-2008 61RBY07 3005384829 Laboratorios Rangel C. Por A. Dominican Republic
112-1453988-7/1/1 21-Aug-2008 61RCY01 3003679311 Universal Marine Med Supplies United States
411-8164487-7/8/2 18-Aug-2008 61SBJ99 3005353382 Wonder Products India
AEK-9124056-0/3/1 11-Aug-2008 61TCF15 3007025508 Rajendra D Patel India
112-3541721-2/6/1 08-Aug-2008 61TCS17 3005601327 Dong Gang Da Chuan Wooden Factory China
322-2936448-7/1/1 14-Aug-2008 61TOR12 3002806754 Cosma S.P.A. Italy
XXX-0149699-2/1/2 01-Aug-2008 61WBJ04 3001319533 UNKNOWN MANUFACTURER IN MEXICO Mexico
112-1662511-4/1/1 21-Aug-2008 61WCA47 3006705520 Yessioa Magda Perez Dominguez Mexico
112-3762659-6/1/1 06-Aug-2008 61WDB52 3004534467 Loeffler S.A. de C.V. Mexico
112-1696147-7/1/2 22-Aug-2008 61XCA99 3006709408 Shering Plough United States
AEK-9124056-0/2/1 11-Aug-2008 61XCF45 3007025508 Rajendra D Patel India
224-0360975-7/1/6 04-Aug-2008 61XCP18 1420763 Medique Products United States
224-0360975-7/1/1 04-Aug-2008 61XPC18 3002138941 Baxter Health Care United States