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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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-8607261-0/1/1 29-Sep-2011 62BCB13 3008493416 Genzyme Belgium
 
BDF-0023525-3/1/1/B 01-Sep-2011 62FBK34 3004122598 Productos Medline, S.A. de C.V. Mexico
 
DV1-0130186-4/1/1 21-Sep-2011 62FBL17 3009100912 oxytam , sa de cv Mexico
 
429-0849342-4/8/3 12-Sep-2011 62GAL99 3004287224 Ravi Spice Processors Pvt. Ltd. India
 
429-0849342-4/8/2 12-Sep-2011 62GAL99 3004287224 Ravi Spice Processors Pvt. Ltd. India
 
429-0849342-4/8/1 12-Sep-2011 62GAL99 3004287224 Ravi Spice Processors Pvt. Ltd. India
 
M21-0744572-0/4/1 22-Sep-2011 62GBA41 3006094247 Research Pharmaceutical Co Ltd China
 
NV3-0044078-5/1/1 27-Sep-2011 62GBY99 3004680223 Taiwan Three Mast Pharmaceutical Co.Ltd. Taiwan
 
408-1286699-1/1/19 22-Sep-2011 62GBZ41 3008384335 GFA Production Xiamen Co. Ltd. China
 
112-9195968-6/1/1 09-Sep-2011 62GCA10 3005154690 Rotomec S.P.A. Italy
 
112-3388617-0/1/1 16-Sep-2011 62GCB18 3009051483 Corp. Bonima Dominican Republic
 
112-8991674-8/1/1 09-Sep-2011 62GCE99 3006437813 Taizhou Highsun Pharmaceutical Co Ltd China
 
112-3749811-3/1/1 30-Sep-2011 62KAY10 3003631185 Nature Vet Pty Ltd Australia
 
112-3962986-3/1/1 30-Sep-2011 62LCB49 3002807585 Mepha LLC Switzerland
 
315-8159008-5/15/1 09-Sep-2011 62LCM50 3008218429 Industria Farmaceutica Nova Argenti Italy
 
315-8159008-5/3/1 09-Sep-2011 62LCP99 3008361715 Dafra Pharma Ltd United Kingdom
 
315-8159008-5/14/1 09-Sep-2011 62LDA44 3005265636 Gsk United Kingdom
 
315-8159008-5/8/1 09-Sep-2011 62LDA99 3003699941 Cipla Ltd India
 
UPS-2981526-9/1/1 21-Sep-2011 62LLL47 3003446831 Fludan Fine Chemicals Inc Canada
 
XXX-0176110-6/1/1 07-Sep-2011 62MBJ08 3003929522 Noelville Ltd. Grenada
 
CDF-2037737-3/9/1 21-Sep-2011 62MBL08 1519375 The Hygenic Corporation United States
 
ANP-0027384-8/1/1 19-Sep-2011 62MLK08 3003583809 Cho Seon Pharm & Trading Co Ltd Korea, Republic Of (South)
 
112-2788751-5/2/1 23-Sep-2011 62NCS01 3008989855 Agon Pharma Pvt. Ltd. India
 
112-3478974-6/1/5 26-Sep-2011 62OCA14 3005890633 Intas Pharmaceuticals India
 
112-8032212-8/1/1 09-Sep-2011 62OCA41 3002703324 Merck Sharp & Dohme De Venezuela Ca Venezuela
 
112-7230468-8/1/3 07-Sep-2011 62OCP41 3005020880 Serdia Pharmaceuticals (India) India
 
UPS-3415795-4/1/1 13-Sep-2011 62OCY41 3002807664 Merck Sharp & Dohme (Italia) S.p.A. Italy
 
112-8643557-7/1/1 26-Sep-2011 62ODB41 3004828308 Merck & Co Canada
 
M21-0744572-0/5/1 22-Sep-2011 62ODS20 3006094247 Research Pharmaceutical Co Ltd China
 
UPS-3145458-6/1/1/B 06-Sep-2011 62SBJ99 3008513058 C-Max Canada Ltd Canada
 
UPS-3249201-5/2/1/A 15-Sep-2011 62SBJ99 3004612704 Cover Fx Skin Care Inc Canada
 
UPS-3450953-5/1/2 14-Sep-2011 62TAY06 3002829763 Astra Zeneca Canada
 
112-8604809-9/2/1 29-Sep-2011 62TCF07 3004684201 LABORATORIOS ALMIRALL S.A. Spain
 
M21-0744593-6/1/1 27-Sep-2011 62UAS99 3006094247 Research Pharmaceutical Co Ltd China
 
315-8159008-5/1/1 09-Sep-2011 62VCA18 3005206955 Wockhardt Uk Ltd United Kingdom
 
112-7206159-3/1/1 07-Sep-2011 62VDA42 3002721084 Teva Pharmaceutical Industies, Ltd. Israel
 
112-7206159-3/1/2 07-Sep-2011 62VDA42 3002721084 Teva Pharmaceutical Industies, Ltd. Israel
 
FY6-2008052-0/11/1 27-Sep-2011 62WAY05 3001782565 Procter & Gamble Co United States
 
FY6-2008052-0/12/1 27-Sep-2011 62WAY05 3001782565 Procter & Gamble Co United States
 
FY6-2008052-0/13/1 27-Sep-2011 62WAY05 3001782565 Procter & Gamble Co United States
 
112-2894235-0/1/1/L 16-Sep-2011 62WBL14 3001441804 Cellex International Canada
 
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