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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 United States


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
UPS-7367741-7/8/1 05-Sep-2012 76EFK 2518040 Integra York PA, Inc
 
UPS-7367741-7/8/2 05-Sep-2012 76EJY 2518040 Integra York PA, Inc
 
UPS-7367741-7/8/3 05-Sep-2012 79LRY 2518040 Integra York PA, Inc
 
600-7287493-0/1/1 05-Sep-2012 90MOS 3009511413 Ge Medical
 
600-7287493-0/1/2 05-Sep-2012 80LDQ 3009511413 Ge Medical
 
600-7288789-0/1/1 05-Sep-2012 90MOS 3000172423 General Electric
 
UT4-0085444-4/1/1 06-Sep-2012 21GGH15 3001239055 Wilbur Packing Co, Inc.
 
DE8-1201214-9/1/18 07-Sep-2012 53ED06 3005522062 Matrix Essentials
 
112-9109734-8/1/1 07-Sep-2012 74DQY 3006646601 Vascular Solutions
 
112-2441278-8/1/1 11-Sep-2012 64BCK24 3005579246 Hospira Inc.
 
112-2441278-8/1/14 11-Sep-2012 56ICO10 3003782540 E. Fougers & Co.
 
112-2441278-8/1/18 11-Sep-2012 62FCO52 3004688211 GlaxoSmithKline
 
112-2441278-8/1/27 11-Sep-2012 66SCA27 3008938510 Phizer Hosp Pdts Group
 
112-2441278-8/1/32 11-Sep-2012 65QCA60 2431855 Pliva Inc
 
112-2441278-8/1/33 11-Sep-2012 61FCH30 3003092769 Teva Pharmaceuticals USA
 
112-2441278-8/1/37 11-Sep-2012 60WCA16 3003092769 Teva Pharmaceuticals USA
 
112-2441278-8/1/43 11-Sep-2012 60LCA01 3006461997 Akyma Pharmaceuticals
 
112-2441278-8/1/50 11-Sep-2012 62FCK17 1025121 Vi-Jon, Inc.
 
112-2441278-8/1/2 11-Sep-2012 64BCK24 3005579246 Hospira Inc.
 
112-2441278-8/1/16 11-Sep-2012 63ECK18 3002160581 Fujisawa Health Care Inc
 
112-2441278-8/1/22 11-Sep-2012 62OCA29 3002047518 IVAX Pharmaceuticals
 
112-2441278-8/1/25 11-Sep-2012 64CCK02 2127022 Paddock Laboratories, LLC
 
112-2441278-8/1/56 11-Sep-2012 61XCK18 3005579246 Hospira Inc.
 
112-2441278-8/1/57 11-Sep-2012 61TCK14 3005579246 Hospira Inc.
 
112-2441278-8/1/61 11-Sep-2012 60CCK04 3005579246 Hospira Inc.
 
112-2441278-8/1/63 11-Sep-2012 61XCK18 3005579246 Hospira Inc.
 
112-2441278-8/1/66 11-Sep-2012 60CCA57 1818658 The Harvard Drug Group, LLC
 
112-2441278-8/1/67 11-Sep-2012 60JCK02 3003433073 Pharmatek
 
112-2441278-8/1/3 11-Sep-2012 62CCH47 3003092769 Teva Pharmaceuticals USA
 
112-2441278-8/1/9 11-Sep-2012 61TCK17 1000429220 Baxter Healthcare Corp
 
112-2441278-8/1/19 11-Sep-2012 63FCK04 3007379904 Glasko Wellcome
 
112-2441278-8/1/21 11-Sep-2012 62GCK94 3005579246 Hospira Inc.
 
112-2441278-8/1/23 11-Sep-2012 60SCA06 3002047518 IVAX Pharmaceuticals
 
112-2441278-8/1/49 11-Sep-2012 56ACA20 3008938507 Gsms
 
112-2441278-8/1/62 11-Sep-2012 62OCK13 3005579246 Hospira Inc.
 
112-2441278-8/1/64 11-Sep-2012 62GCA41 3008938508 Interpharm
 
112-2441278-8/1/65 11-Sep-2012 61WCO18 1818658 The Harvard Drug Group, LLC
 
112-2441278-8/1/4 11-Sep-2012 61KCK62 1610287 Alcon Research, Ltd.
 
112-2441278-8/1/5 11-Sep-2012 61KCK62 1610287 Alcon Research, Ltd.
 
112-2441278-8/1/7 11-Sep-2012 64LCK37 1000113778 Bausch & Lomb, Inc.
 
112-2441278-8/1/15 11-Sep-2012 56ICO10 3003782540 E. Fougers & Co.
 
112-2441278-8/1/26 11-Sep-2012 63ICK01 2127022 Paddock Laboratories, LLC
 
112-2441278-8/1/28 11-Sep-2012 63WCK07 3002960808 PURDUE Pharmaceuticals Lp
 
112-2441278-8/1/41 11-Sep-2012 61NCO80 3008938512 Wyeth Pharmaceuticals Company
 
112-2441278-8/1/51 11-Sep-2012 65FIK99 3005579246 Hospira Inc.
 
112-2441278-8/1/54 11-Sep-2012 65RCK17 3005579246 Hospira Inc.
 
112-2441278-8/1/55 11-Sep-2012 60CCK04 3005579246 Hospira Inc.
 
112-2441278-8/1/6 11-Sep-2012 62LCO52 2024601 Allergan
 
112-2441278-8/1/8 11-Sep-2012 64LCK37 1000113778 Bausch & Lomb, Inc.
 
112-2441278-8/1/10 11-Sep-2012 61TCK17 1000429220 Baxter Healthcare Corp
 
112-2441278-8/1/12 11-Sep-2012 60CCY04 3008751485 Dey Pharma
 
112-2441278-8/1/17 11-Sep-2012 62LCA49 3008938506 Geneva Pharmaceuticals Tech.
 
112-2441278-8/1/20 11-Sep-2012 60CCK04 3005579246 Hospira Inc.
 
112-2441278-8/1/24 11-Sep-2012 64ADA04 3004758118 Merck & Co Inc
 
112-2441278-8/1/30 11-Sep-2012 60SCA04 1419642 Rugby Laboratories, Inc.
 
112-2441278-8/1/38 11-Sep-2012 56CCH73 3003092769 Teva Pharmaceuticals USA
 
112-2441278-8/1/47 11-Sep-2012 61NCA49 2450054 Perrigo New York
 
112-2441278-8/1/11 11-Sep-2012 61TCK17 3008938505 Danbury Pharmacal
 
112-2441278-8/1/13 11-Sep-2012 60CCA57 1922351 KV Pharmaceutical Co
 
112-2441278-8/1/29 11-Sep-2012 61TCA11 1419642 Rugby Laboratories, Inc.
 
112-2441278-8/1/31 11-Sep-2012 63BCQ27 1222021 Sunovion Pharmaceuticals Inc.
 
112-2441278-8/1/39 11-Sep-2012 64LCO28 3003092769 Teva Pharmaceuticals USA
 
112-2441278-8/1/52 11-Sep-2012 65FIK99 3005579246 Hospira Inc.
 
112-2441278-8/1/53 11-Sep-2012 65FIK99 3005579246 Hospira Inc.
 
112-2441278-8/1/58 11-Sep-2012 65FIK99 3005579246 Hospira Inc.
 
112-2441278-8/1/34 11-Sep-2012 62KCH08 3003092769 Teva Pharmaceuticals USA
 
112-2441278-8/1/35 11-Sep-2012 62LCA50 3003092769 Teva Pharmaceuticals USA
 
112-2441278-8/1/36 11-Sep-2012 61WCO47 3003092769 Teva Pharmaceuticals USA
 
112-2441278-8/1/42 11-Sep-2012 60QCK07 3006441852 Abraxis Bioscience LLC
 
112-2441278-8/1/44 11-Sep-2012 61KCK05 3002936358 Amphastar Pharmaceuticals, Inc.
 
112-2441278-8/1/48 11-Sep-2012 60QCO34 2450054 Perrigo New York
 
112-2441278-8/1/60 11-Sep-2012 64BCK24 3005579246 Hospira Inc.
 
AEK-0437422-5/1/1 12-Sep-2012 86MVN 2916547 ABB CONCISE OPTICAL GROUP, LLC
 
336-5456865-2/3/1 13-Sep-2012 53AC02 3007262486 Burt's Bees Inc.
 
E8L-1016785-1/1/1 17-Sep-2012 53IH01 3009629136 Franklin Botanical Laboratory Inc
 
BOS-0039167-5/1/1 18-Sep-2012 78FJK 3001451489 Fresenius Medical Care Holdings, Inc.
 
UPS-7182829-3/1/1 18-Sep-2012 54FYR99 3008615086 IntegraCore, LLC
 
322-0761112-4/2/1 21-Sep-2012 28BGH08 1122618 Elite Spice Inc.
 
GEO-8500111-9/1/1 26-Sep-2012 66VCY99 1000132620 Holland America Line -
 
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