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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
M76-9931377-2/1/1 03-Aug-2009 79KKX 3006653341 Amsco Sterile Recoveries Inc
 
M76-9931377-2/3/1 03-Aug-2009 79FYA 3006653343 Lacmac Limited Innerbloc Or Gow
 
XXX-0256051-5/1/1 03-Aug-2009 61NCB05 1035048 GlaxoSmithKline
 
112-8027126-6/1/2 04-Aug-2009 66PBJ99 1611064 Goodier Cosmetics, Lp
 
UPS-1233661-0/70/1 06-Aug-2009 86HQY 3007665907 L W Barret Co Inc
 
112-8310718-6/1/1 07-Aug-2009 86LPL 1000103392 ABB Concise Optical Group LLC
 
235-1460273-1/1/1 10-Aug-2009 12AGO05 2123818 Dairy Farmers of America
 
AEK-9912331-3/1/1 14-Aug-2009 57FY88 1219613 Moore Medical LLC
 
235-1461124-5/1/1 17-Aug-2009 79GEX 3003370413 Amo Puerto Rico Manufacturing Inc.
 
112-5415134-6/1/1 18-Aug-2009 87KTT 3004138933 Bmlc
 
112-6506487-6/1/1 18-Aug-2009 79GEX 3007377095 Biocell
 
112-6469035-8/1/1 18-Aug-2009 62TCA02 3004447666 Takeda Global Research & Development
 
112-6354280-8/1/1 19-Aug-2009 66VAA99 3001239031 Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals
 
112-6580908-0/1/1/B 19-Aug-2009 54YDA99 1217981 FoodScience Corporation
 
112-6609259-5/1/1 19-Aug-2009 86HOY 3007390782 Russell Terry Medical
 
112-6821347-0/1/1 20-Aug-2009 63BCQ02 3004383917 Glakosmithcline
 
112-6821347-0/1/2 20-Aug-2009 62CCA65 2518137 AstraZeneca Pharmaceuticals LP
 
KG2-0525948-7/2/1 20-Aug-2009 24CEY99 2911502 Del Monte Foods, Inc.
 
KG2-0525948-7/3/1 20-Aug-2009 24CEY60 2911502 Del Monte Foods, Inc.
 
KG2-0525948-7/5/1 20-Aug-2009 24VEY08 2911502 Del Monte Foods, Inc.
 
KG2-0525948-7/6/1 20-Aug-2009 25JET06 2911502 Del Monte Foods, Inc.
 
KG2-0525948-7/9/1 20-Aug-2009 25NEN08 2911502 Del Monte Foods, Inc.
 
KG2-0525948-7/4/1 20-Aug-2009 24CEY14 2911502 Del Monte Foods, Inc.
 
K10-4105253-7/1/1 20-Aug-2009 54HCL04 3002730592 Jedwards International Inc.
 
112-6699176-2/1/1 21-Aug-2009 46YH99 3004305343 Aloha Medicinals Inc.
 
AEK-9747884-2/1/1 21-Aug-2009 65PDY99 3007116542 Marabou Ltd
 
BHC-5003124-2/1/1 21-Aug-2009 65VDE40 3004991673 Celgene Corporation
 
BHC-5003124-2/2/1 21-Aug-2009 64LDY67 3005074698 Stiefel Laboratories Ltd
 
BHC-5003124-2/3/1 21-Aug-2009 64TDA01 3009325614 Salix Pharmaceuticals Inc
 
BHC-5003124-2/4/1 21-Aug-2009 60XDA20 3006234685 Mylan Lab Inc
 
BHC-5003124-2/4/2 21-Aug-2009 62YDA07 3006234685 Mylan Lab Inc
 
BHC-5003124-2/4/3 21-Aug-2009 61KDB34 3006234685 Mylan Lab Inc
 
BHC-5003124-2/5/1 21-Aug-2009 63BBZ32 2210048 Merck, Inc.
 
BHC-5003124-2/6/1 21-Aug-2009 56IDL25 3007702682 Abbott Pharmaceuticals
 
BHC-5003124-2/6/2 21-Aug-2009 61MDA35 3007702682 Abbott Pharmaceuticals
 
BHC-5003124-2/7/1 21-Aug-2009 62CDA68 3003089536 Daiichi Sankyo Inc.
 
BHC-5003124-2/8/1 21-Aug-2009 75NBW 3002803444 Abbott Diabetes Care, Inc.
 
BHC-5003124-2/8/2 21-Aug-2009 75NBW 3002803444 Abbott Diabetes Care, Inc.
 
BHC-5003124-2/9/1 21-Aug-2009 64XDK12 3007702690 Ortho-Mcneil
 
BHC-5003124-2/10/1 21-Aug-2009 65VDH07 3004530896 Shionogi Inc.
 
BHC-5003124-2/11/1 21-Aug-2009 62IDA30 3003092769 Teva Pharmaceuticals USA
 
BHC-5003124-2/11/2 21-Aug-2009 60LDA14 3003092769 Teva Pharmaceuticals USA
 
BHC-5003124-2/11/3 21-Aug-2009 62VDH18 3003092769 Teva Pharmaceuticals USA
 
BHC-5003124-2/12/1 21-Aug-2009 61PDA61 1000522100 GlaxoSmithKline LLC
 
BHC-5003124-2/13/1 21-Aug-2009 61ADA06 3007576384 Global Pharmaceutical
 
BHC-5003124-2/14/1 21-Aug-2009 75NBW 1000113657 Nipro Diagnostics, Inc.
 
BHC-5003124-2/15/1 21-Aug-2009 61QDQ03 1313525 Bausch & Lomb Inc
 
BHC-5003124-2/16/1 21-Aug-2009 56CDA52 3007573414 Dava Pharmaceuticals Inc
 
BHC-5003124-2/17/1 21-Aug-2009 64LDY06 3002968915 E. Fougera & Company
 
BHC-5003124-2/18/1 21-Aug-2009 64XDO12 1811666 L. Perrigo Co.
 
BHC-5003124-2/19/1 21-Aug-2009 63RDY06 2418748 Colgate Palmolive Co
 
BHC-5003124-2/20/1 21-Aug-2009 63FDA06 1833173 Sun Pharmaceutical Industries, Inc
 
BHC-5003124-2/21/1 21-Aug-2009 66VDB99 3007702688 Midlothian Laboratories
 
BHC-5003124-2/22/1 21-Aug-2009 64XDO12 3005130594 Triax Pharmaceuticals, LLC
 
BHC-5003124-2/23/1 21-Aug-2009 61HDH32 3007702691 Ranbaxy-Generic Products
 
BHC-5003124-2/23/2 21-Aug-2009 62ODA34 3007702691 Ranbaxy-Generic Products
 
BHC-5003124-2/23/3 21-Aug-2009 61WDL23 3007702691 Ranbaxy-Generic Products
 
BHC-5003124-2/24/1 21-Aug-2009 56BDL03 1717759 Sandoz Incorporated
 
BHC-5003124-2/25/1 21-Aug-2009 61NDA82 3007702687 Janssen Pharmaceuticals
 
BHC-5003124-2/26/1 21-Aug-2009 62KDA08 3007702683 American Fare
 
BHC-5003124-2/27/1 21-Aug-2009 61KDA06 3001611969 Excellium Pharmaceutical, Inc
 
BHC-5003124-2/28/1 21-Aug-2009 56CDK70 3006727872 Apotex Corp.
 
BHC-5003124-2/29/1 21-Aug-2009 60SDA22 3003359727 Par Pharmaceuticals
 
BHC-5003124-2/30/1 21-Aug-2009 62LDH40 3000718267 Barr Laboratories, Inc. (div. Of Teva)
 
BHC-5003124-2/31/1 21-Aug-2009 61LDK27 3006614085 Eisai Inc
 
BHC-5003124-2/32/1 21-Aug-2009 60QDL07 1420913 Morton Grove Pharmaceuticals, Inc.
 
BHC-5003124-2/33/1 21-Aug-2009 60SDL06 1000416547 Pfizer Inc.
 
BHC-5003124-2/34/1 21-Aug-2009 66MDA60 3010368539 Url Pharma
 
BHC-5003124-2/34/2 21-Aug-2009 60SDA23 3010368539 Url Pharma
 
BHC-5003124-2/35/1 21-Aug-2009 62ODA14 3002896610 Ethex Corp
 
BHC-5003124-2/36/1 21-Aug-2009 62JDA15 1219205 Boehringer Ingelheim Pharmaceuticals, Inc.
 
101-8255498-9/1/1 21-Aug-2009 54YCS99 2515821 HVL, LLC
 
AEK-9747884-2/1/2 21-Aug-2009 65PDY99 3007116542 Marabou Ltd
 
AEK-9747884-2/1/3 21-Aug-2009 65PDY99 3007116542 Marabou Ltd
 
112-6346279-1/14/1 26-Aug-2009 53GY03 2430738 Mana Products, Inc.
 
112-6346279-1/17/1 26-Aug-2009 53GY03 2430738 Mana Products, Inc.
 
112-7296400-1/1/1 26-Aug-2009 80FRN 3002936294 Curlin Medical Llc
 
112-7296501-6/1/1 26-Aug-2009 61NIB05 3006891219 Bayer Pharmaceutircals Corp
 
112-7296501-6/1/2 26-Aug-2009 61NIB05 3007520787 Pfizer Pharmaceuticals Inc
 
112-7307474-3/1/1 26-Aug-2009 81GJS 3003038758 Hemosense Inc
 
112-7307474-3/1/2 26-Aug-2009 75CHH 1000123985 Cholestech Corp
 
112-7251336-0/1/1 26-Aug-2009 81GJS 3003038758 Hemosense Inc
 
112-7251519-1/1/2 28-Aug-2009 81GJS 3003038758 Hemosense Inc
 
791-6272936-6/1/1 28-Aug-2009 23CGE99 3007559409 John Sanfilippo
 
112-7156520-5/1/1 28-Aug-2009 56EAP20 3006274485 International Pharmacy Services
 
231-9427046-1/10/3 31-Aug-2009 55RP99 3007554070 Harmony Labs
 
231-9427046-1/8/1 31-Aug-2009 53CH03 2919184 Columbia Cosmetics Manufacturing, Inc.
 
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