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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 61-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
M21-0745477-1/1/1 22-Mar-2012 61ECS99 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-6303879-1/3/1 20-Mar-2012 61FCC53 3005400311 Bristol Myers Squidd Ecuador
 
HK8-0050336-7/5/1 01-Mar-2012 61HBL99 3006403682 Jiangsu Province Jianerkang Medical Dressing Co. China
 
EUV-0001561-2/1/24 26-Mar-2012 61HBL99 3008357570 Rafael A. Castillo Dominican Republic
 
CFU-4108005-2/2/1 09-Mar-2012 61HBY99 3008989967 Become International Australia
 
112-5999829-7/1/1 30-Mar-2012 61HCL99 3004189889 Sbl Distribution Sweden
 
144-4471963-0/1/1 08-Mar-2012 61HDL45 3001581899 Contract Pharmaceuticals Ltd. Canada
 
112-6455684-1/2/2 30-Mar-2012 61JCA08 2416101 Pfizer Inc. United States
 
112-6324392-0/1/1 30-Mar-2012 61JCS11 3003560263 Hikal Ltd. India
 
112-6324392-0/1/2 30-Mar-2012 61JCS11 3003560263 Hikal Ltd. India
 
UPS-5471904-8/1/2 23-Mar-2012 61JCY11 3009423026 Flor Maria Sabogal Colombia
 
AEK-0085207-5/1/2 23-Mar-2012 61JCY16 3009401588 Pasupathy India
 
112-6523823-3/1/1 29-Mar-2012 61JDB09 3006576762 Amherst Laboratories Philippines
 
AEK-0085207-5/1/4 23-Mar-2012 61JDY08 3009401588 Pasupathy India
 
ARV-2313497-1/2/1 12-Mar-2012 61KBA46 3009419103 Nordia Pharmaceutical Company Denmark
 
112-5681902-5/1/1 05-Mar-2012 61LCA13 1000645857 Bristol-Meyers Squibb Co United States
 
AEK-0085207-5/1/1 23-Mar-2012 61LCY38 3009401588 Pasupathy India
 
112-5820839-1/1/1 05-Mar-2012 61MCB42 3003399463 Ucb, Inc United States
 
112-5516111-4/1/1 02-Mar-2012 61MIY42 3003399463 Ucb, Inc United States
 
112-5812689-0/2/2 14-Mar-2012 61NCA65 3003640502 Lundbeck Canada Inc Canada
 
112-6030466-7/1/1 20-Mar-2012 61NCH29 3009352534 Emss Brazil
 
112-5860326-0/1/1 05-Mar-2012 61NDB80 3002807756 Teva Canada Limited Canada
 
AEK-8396917-6/1/1 29-Mar-2012 61PCA26 3009415429 Selim Sheikh Bangladesh
 
XXX-0249613-2/1/5 05-Mar-2012 61PCY17 3003195501 Sanofi-Aventis Deutschland GmbH Germany
 
XXX-0249613-2/1/4 05-Mar-2012 61PCY58 3006304669 Eli Lilly & Co United States
 
112-5813340-9/3/1 14-Mar-2012 61TCA06 3004540127 Wallace Pharmaceuticals Ltd India
 
AEK-8396917-6/3/1 29-Mar-2012 61TCA31 3009415429 Selim Sheikh Bangladesh
 
112-6061642-5/1/1 07-Mar-2012 61UCK06 3009381270 Orion Pharmaceuticals United Kingdom
 
M21-0745512-5/1/1 19-Mar-2012 61WCA47 3006094247 Research Pharmaceutical Co Ltd China
 
XXX-0249076-2/1/2 05-Mar-2012 61WCY04 3004258511 Catalent Argentina S.A.I.C. Argentina
 
XXX-0223864-1/1/2 14-Mar-2012 61WCY04 3006577809 Catalent Argentina S A I C Argentina
 
112-6095832-2/2/1 06-Mar-2012 61XBA45 3004006471 Glaxo Smith Kline United States
 
AEK-8397662-7/1/1 30-Mar-2012 61XCA09 3009428560 Nenad Petrovski Macedonia
 
112-6401878-4/1/1 30-Mar-2012 61XCS15 1000288672 MSD (Merck Sharp Dohme) Ireland -Rathdrum Ireland
 
XXX-0278754-8/1/3 05-Mar-2012 61XCY45 3005170438 Bago Chile
 
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