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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 65-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-6586434-3/1/1 19-Jun-2012 65ACC99 3008739240 J Uriach Y Compan Spain
 
112-9648810-3/2/4 01-Jun-2012 65CDJ04 3005466252 Glenmark Pharmaceuticals LTD India
 
785-1644575-2/1/1 07-Jun-2012 65GDJ99 3009509168 Dermosciences Limited Ireland
 
XXX-0285577-4/1/1 01-Jun-2012 65JCE21 3003637173 Pfizer Italia S.p.A Italy
 
112-5499455-5/1/1 19-Jun-2012 65JCH31 3006705464 Schering-Plough Canada Inc Canada
 
112-5568855-2/1/1 20-Jun-2012 65JDA39 3008099551 Onno Helene Gaandrse Canada
 
112-6021260-5/2/1 15-Jun-2012 65JDJ31 3009351998 Merck Serono United Kingdom
 
XXX-0238437-9/1/1 25-Jun-2012 65JDY04 3006343435 Grunenthal Gmbh Germany
 
112-7500186-0/1/1/A 29-Jun-2012 65KCK10 1643525 Allergan Sales, LLC United States
 
KR4-0042649-9/27/1 11-Jun-2012 65LBJ13 3003029000 Jafra Manufactuing S.A. de C.V. Mexico
 
KR4-0042649-9/15/1 11-Jun-2012 65LBJ15 3003029000 Jafra Manufactuing S.A. de C.V. Mexico
 
M50-0214390-2/4/1 27-Jun-2012 65LBJ99 3003224597 Unilever Canada Canada
 
XXX-0178111-2/2/2 28-Jun-2012 65LBL06 3004341688 P.A. Benjamin Manufacturing Co., Ltd. Jamaica
 
UPS-5356685-3/1/15 29-Jun-2012 65LBL11 3009404666 Zo Skin United States
 
UPS-5356685-3/1/16 29-Jun-2012 65LBL11 3009404666 Zo Skin United States
 
KR4-0042726-5/24/1 26-Jun-2012 65LBR11 3003029000 Jafra Manufactuing S.A. de C.V. Mexico
 
FV4-5038374-3/2/5 14-Jun-2012 65LBU99 3007292644 Kim Jeong Moon Aloe Co., Ltd. Korea, Republic Of (South)
 
112-6494249-5/1/1 19-Jun-2012 65LPJ99 3004504829 Julphar Gulf Pharmaceutical Industries United Arab Emirates
 
112-0431695-9/1/1 01-Jun-2012 65PBB02 3008716135 Nutripharma Ltda Colombia
 
112-9227757-5/1/1 07-Jun-2012 65PCA02 3008562526 G D Gupta India
 
112-9228144-5/1/1 07-Jun-2012 65PCA02 3008562528 Lopez V Guadaloupe Mexico
 
112-6744692-4/1/1 20-Jun-2012 65PCE03 3003369663 Cadila Healthcare Ltd India
 
112-7037447-7/1/1 18-Jun-2012 65PDA02 3004742797 Pfizer Phils Philippines
 
AEK-0185885-7/1/1 05-Jun-2012 65PIY02 3009183838 Amtec Healthcare Pvt Ltd India
 
112-7135511-2/1/1 08-Jun-2012 65QAF22 3009493797 Baxter Healthcare United States
 
112-8708629-6/1/2 07-Jun-2012 65QCB60 3008503792 Rx R Us Pharmacy Canada
 
UPS-6886081-2/1/1 22-Jun-2012 65QDL99 3009612738 ArgirelineAntiWrinkle Switzerland
 
KM6-0057218-4/8/1 29-Jun-2012 65RBZ18 3009498041 Bhudarbhai Karsshandas Gandhi India
 
AEK-0279092-7/1/1 05-Jun-2012 65UBA02 3009510224 Laboratorio Novartis Biociencias Brazil
 
112-5536178-8/2/1 20-Jun-2012 65VCA41 3007402809 Pfizer Italia Srl Italy
 
112-7011726-4/1/1 08-Jun-2012 65VCC13 3000281296 Novartis Pharma Canada Canada
 
112-6774550-8/1/1 19-Jun-2012 65VIL99 1000493249 Laboratoires Lehning SA France
 
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