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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 64-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
HD8-0089119-8/1/1/G 05-Aug-2008 64ABY19 3003233566 Vinco Pharmaceuticals United Kingdom
 
HD8-0089119-8/1/1/I 05-Aug-2008 64ABY19 3006513157 Tura International Ltd. Nigeria
 
201-3055824-9/1/1 07-Aug-2008 64BCS25 3004021229 Aurobindo Pharma Ltd India
 
112-3878754-6/3/1 14-Aug-2008 64BDC24 3004735943 Handok Pharmaceuticals Co Ltd Korea, Republic Of (South)
 
UPS-2027623-2/1/1 29-Aug-2008 64GDA19 3007067248 El Dorado Royal A Spa Resort Mexico
 
HD8-0089119-8/1/1/B 05-Aug-2008 64LAJ67 3003475851 Vinco Corporation Italy
 
HD8-0089119-8/1/1/C 05-Aug-2008 64LAJ67 3009853808 Beltapharma SPA Subsidary of Strides Arcolab International Italy
 
429-0772409-2/1/1/A 18-Aug-2008 64LCO67 3005063101 Abdallah Omar Ahmed Saudi Arabia
 
429-0772409-2/1/1/B 18-Aug-2008 64LCO67 3005063101 Abdallah Omar Ahmed Saudi Arabia
 
429-0772409-2/1/1/C 18-Aug-2008 64LCO67 3005063101 Abdallah Omar Ahmed Saudi Arabia
 
429-0772421-7/7/1/A 18-Aug-2008 64LCO67 3007045804 Ayman Said Bdallah Saudi Arabia
 
429-0772421-7/7/1/B 18-Aug-2008 64LCO67 3007045804 Ayman Said Bdallah Saudi Arabia
 
HD8-0089119-8/1/2/A 05-Aug-2008 64LDJ06 3003475851 Vinco Corporation Italy
 
HD8-0089119-8/1/2/D 05-Aug-2008 64LDJ06 3009853808 Beltapharma SPA Subsidary of Strides Arcolab International Italy
 
HD8-0089119-8/1/2/E 05-Aug-2008 64LDJ06 3003475851 Vinco Corporation Italy
 
HD8-0089119-8/1/2/F 05-Aug-2008 64LDJ08 3006784558 LABORATE India
 
HD8-0089119-8/1/2/B 05-Aug-2008 64LDJ28 1000167943 MCA Medical And Chemical Agency S.R.L. Italy
 
HD8-0089119-8/1/2/C 05-Aug-2008 64LDJ28 1000167943 MCA Medical And Chemical Agency S.R.L. Italy
 
HD8-0089119-8/1/1/D 05-Aug-2008 64LDJ45 3000264888 Patheon Inc. - Toronto Region Operations Canada
 
112-1658193-7/2/1 21-Aug-2008 64LDO67 3005473546 Glaxo Smith Kline Sae Co. Egypt
 
UPS-1704055-9/1/7 04-Aug-2008 64LOK19 3006636130 Bimeda North America United States
 
XXX-0155439-4/1/1 25-Aug-2008 64RDY19 3007062747 New Life Pharmacy United States
 
112-1825882-3/1/2 21-Aug-2008 64SCP29 3003414667 Laboratoire Aventis France
 
M76-8510336-9/1/1 22-Aug-2008 64TCJ08 3002160581 Fujisawa Health Care Inc United States
 
M76-8510336-9/3/1 22-Aug-2008 64TCJ08 3002808385 Taro Pharmaceutical Industries, Ltd. Israel
 
M76-8510336-9/2/1 22-Aug-2008 64TCJ08 3002808385 Taro Pharmaceutical Industries, Ltd. Israel
 
112-1415225-1/1/1 22-Aug-2008 64UAA06 3004758118 Merck & Co Inc United States
 
336-6506327-0/2/1 14-Aug-2008 64WAK99 3002378141 Goemar Laboratories France
 
336-6506327-0/1/1 14-Aug-2008 64WAK99 3002378141 Goemar Laboratories France
 
336-6506328-8/1/1 14-Aug-2008 64WAK99 3002378141 Goemar Laboratories France
 
336-6506326-2/1/1 18-Aug-2008 64WAK99 3002378141 Goemar Laboratories France
 
M50-0003272-7/34/1/B 01-Aug-2008 64XAL06 3004101514 Reckitt Benckiser United Kingdom
 
M50-0003277-6/35/1 01-Aug-2008 64XAL06 3004101514 Reckitt Benckiser United Kingdom
 
M50-0003272-7/36/1 01-Aug-2008 64XAL06 3004101514 Reckitt Benckiser United Kingdom
 
M50-0003277-6/36/1 01-Aug-2008 64XAL06 3004101514 Reckitt Benckiser United Kingdom
 
M50-0003272-7/37/1 01-Aug-2008 64XAL06 3004101514 Reckitt Benckiser United Kingdom
 
M50-0003277-6/37/1 01-Aug-2008 64XAL06 3004101514 Reckitt Benckiser United Kingdom
 
M50-0003272-7/34/1/A 01-Aug-2008 64XAL06 3004101514 Reckitt Benckiser United Kingdom
 
M50-0003277-6/33/1 01-Aug-2008 64XAL06 3004101514 Reckitt Benckiser United Kingdom
 
461-0067464-0/1/1/A 27-Aug-2008 64XBJ06 3006378654 Tecser Laboratorios Ltda. Colombia
 
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