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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
BJV-0240668-5/6/3 08-Jun-2011 62FAK34 1220701 Aplicare, Inc. United States
 
BJV-0241005-9/39/1 21-Jun-2011 62FAL34 1120159 Aplicare Incorporated United States
 
BJV-0241005-9/63/2 21-Jun-2011 62FAL34 2411192 Professional Disposables International, Inc. United States
 
BJV-0241052-1/3/1 21-Jun-2011 62FAL34 1120159 Aplicare Incorporated United States
 
BJV-0241052-1/3/2 21-Jun-2011 62FAL34 1120159 Aplicare Incorporated United States
 
336-0837832-3/1/1 14-Jun-2011 62FBK17 3002898912 Delon Laboratories Canada
 
BJV-0240668-5/6/1 08-Jun-2011 62FBK20 1484185 3M Company United States
 
BJV-0240668-5/6/2 08-Jun-2011 62FBK20 1484185 3M Company United States
 
BJV-0241005-9/91/1 21-Jun-2011 62FBK20 1484185 3M Company United States
 
BJV-0241052-1/4/1 21-Jun-2011 62FBK20 1484185 3M Company United States
 
BJV-0241052-1/4/2 21-Jun-2011 62FBK20 1484185 3M Company United States
 
336-0837832-3/2/1 14-Jun-2011 62FBK23 3002898912 Delon Laboratories Canada
 
BJV-0240964-8/4/1 17-Jun-2011 62FBL08 2411192 Professional Disposables International, Inc. United States
 
BJV-0240668-5/3/1 08-Jun-2011 62FBL34 2411192 Professional Disposables International, Inc. United States
 
112-2156125-6/2/1/B 17-Jun-2011 62FOS03 3008907578 Pharmasi Chemical China
 
HD8-0099878-7/1/17 16-Jun-2011 62GBL99 3005731350 Leejiham Cosmetics Korea, Republic Of (South)
 
112-1603581-1/1/1 16-Jun-2011 62GBY99 3008846940 Telesky Shopping Pvt Ltd India
 
112-1685501-0/1/1 27-Jun-2011 62GBY99 3008855266 Shree Marwal Sevashram India
 
112-2068220-2/1/1 27-Jun-2011 62GBY99 3007844485 Shenzhen Kingyield Technology Co Ltd China
 
112-2068592-4/1/1 27-Jun-2011 62GBY99 3007844485 Shenzhen Kingyield Technology Co Ltd China
 
UPS-2413535-8/1/4 16-Jun-2011 62GCA49 3008938242 William Parra Paredes Colombia
 
112-2018462-1/1/1 20-Jun-2011 62GCA99 3005208011 Divya Pharmacy Yog India
 
XXX-0265807-9/1/2 29-Jun-2011 62GDY18 3004581852 Laboratorio Farmacaps para Drodijosa Guatemala
 
XXX-0174022-5/1/9 30-Jun-2011 62GDY18 1000467881 Laboratorios Lamfer, S.A. Guatemala
 
112-8609224-5/1/1 15-Jun-2011 62GQX99 3003222551 Ceva Sante Animale France
 
BJV-0240525-7/31/1 08-Jun-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0240668-5/15/1 08-Jun-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0240668-5/17/1 08-Jun-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0240668-5/17/2 08-Jun-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0241005-9/41/1 21-Jun-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0241005-9/45/1 21-Jun-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0241005-9/45/2 21-Jun-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0241052-1/14/2 21-Jun-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
112-2170415-3/1/1 22-Jun-2011 62JCA13 3006595385 Cadila Healthcare Limited India (Zyfine) India
 
112-2170415-3/1/2 22-Jun-2011 62JCA13 3006595385 Cadila Healthcare Limited India (Zyfine) India
 
112-2170415-3/1/3 22-Jun-2011 62JCA13 3006595385 Cadila Healthcare Limited India (Zyfine) India
 
112-2170415-3/1/4 22-Jun-2011 62JCA13 3006595385 Cadila Healthcare Limited India (Zyfine) India
 
112-2170415-3/1/5 22-Jun-2011 62JCA13 3006595385 Cadila Healthcare Limited India (Zyfine) India
 
112-2170415-3/1/6 22-Jun-2011 62JCA13 3006595385 Cadila Healthcare Limited India (Zyfine) India
 
XXX-0174022-5/1/4 30-Jun-2011 62MAY08 3007566202 Laboratorio Trinidad Guatemala
 
AGT-0007236-4/14/1 07-Jun-2011 62MBJ08 3006780965 Global Ind. Nigeria Ltd Nigeria
 
CDF-2033446-5/3/1 03-Jun-2011 62MBL08 1519375 The Hygenic Corporation United States
 
AGT-0007236-4/17/1 07-Jun-2011 62MBL08 3006742009 PZ Nigeria Limited Nigeria
 
429-0848645-1/1/2 24-Jun-2011 62MBR08 3006644764 AMAR REMEDIES LIMITED India
 
XXX-0174022-5/1/7 30-Jun-2011 62MDY01 1000200056 Procter & Gamble De Mexico S.A. Mexico
 
XXX-0174022-5/1/8 30-Jun-2011 62MDY01 1000200056 Procter & Gamble De Mexico S.A. Mexico
 
XXX-0174022-5/1/6 30-Jun-2011 62MDY08 3003631870 GlaxoSmithKline Costa Rica, S.A. Costa Rica
 
906-1077812-9/1/1 02-Jun-2011 62MJS05 3008837328 Societe Monegasque D Estudes Monaco
 
AEK-8374680-6/1/1 02-Jun-2011 62OCA09 3008892828 Rubina Khan India
 
UPS-2413535-8/1/2 16-Jun-2011 62OCA41 3008938242 William Parra Paredes Colombia
 
EH2-0015417-5/4/1 03-Jun-2011 62ODA20 3008616931 Jsc Kievmedpreparat Ukraine
 
UPS-2413535-8/1/6 16-Jun-2011 62ODC43 3008938242 William Parra Paredes Colombia
 
112-2155350-1/1/1 15-Jun-2011 62ODS20 3008906564 Ningbo Samreal Imp.&Exp.Co.Ltd. China
 
XXX-0174022-5/1/25 30-Jun-2011 62QDY07 3006329243 Novartis Farmaceutica S.A De C.V Mexico
 
BDD-0777036-1/12/1 15-Jun-2011 62SAY99 3003725684 Unilever Philippines, Inc. Philippines
 
AEK-8761722-7/1/1 30-Jun-2011 62VBL99 3008943384 Dresevic Rifat Montenegro
 
112-5811333-5/1/1 08-Jun-2011 62VCA99 3008147725 Sanofi-Aventis Singapore
 
UPS-2505555-5/1/1 23-Jun-2011 62VDJ99 3008782479 Chen Naturals Inc Canada
 
KL1-0161270-5/1/1 03-Jun-2011 62WAL99 3005024340 Estee Lauder Companies Pty Ltd South Africa
 
101-8900632-2/4/1 01-Jun-2011 62WBL99 3003690512 Les Emballages Knowlton Inc. Canada
 
D01-0833694-8/1/4 10-Jun-2011 62WBL99 3004055664 Unilever de Mexico S de R.L. de C.V. Mexico
 
101-8900632-2/5/1 01-Jun-2011 62WBY99 3003690512 Les Emballages Knowlton Inc. Canada
 
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