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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 60-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-7458376-9/1/1 19-Jun-2012 60CCA21 3009527523 Fabricante Bristol Mayer Squibb Brazil
 
97Y-0001373-8/2/1 12-Jun-2012 60G99 3006403682 Jiangsu Province Jianerkang Medical Dressing Co. China
 
97Y-0001373-8/3/1 12-Jun-2012 60G99 3006403682 Jiangsu Province Jianerkang Medical Dressing Co. China
 
071-0192206-5/3/22/C 19-Jun-2012 60LAY01 3004565986 Teva Operations Poland sp. z.o.o. Poland
 
071-0192206-5/3/22/B 19-Jun-2012 60LBA05 3004649017 Bayer AG Poland
 
112-7418865-0/1/1/A 19-Jun-2012 60LBH01 3010165392 MEDGEL PRIVATE LIMITED India
 
112-7418865-0/1/1/B 19-Jun-2012 60LBH01 3010165392 MEDGEL PRIVATE LIMITED India
 
AEK-8398896-0/1/1 06-Jun-2012 60LBJ99 3009451180 Marvi Pharmaceuticals Pakistan
 
112-3757315-4/1/1 04-Jun-2012 60LBL99 3009126326 Saptarishi Ayurved Sansthan India
 
K74-0163593-6/10/1 04-Jun-2012 60LBO99 3008454086 Awoudi Konu Togo
 
071-0192206-5/3/22/D 19-Jun-2012 60LBY99 3004172841 Novartis Poland
 
112-5858533-5/2/1 15-Jun-2012 60LCA05 3009044483 Bayer Healthcare Ag Germany
 
112-9306927-8/1/1 07-Jun-2012 60LCA14 3008570896 Capin Point Laboratories India
 
112-7883449-8/2/1 11-Jun-2012 60LCB05 3003255171 Usv Limited India
 
112-8708629-6/1/1 07-Jun-2012 60LCB83 3008503792 Rx R Us Pharmacy Canada
 
M21-0746241-0/1/1 28-Jun-2012 60LCL99 3007522260 Lyka Bdr International Ltd India
 
112-7256692-3/1/1 11-Jun-2012 60LDA01 3004485327 Bristol-Myers Sqibb France
 
112-5810528-2/1/2 15-Jun-2012 60LPK71 3009329110 Pisa Agropecuaria Sa De Cv Mexico
 
112-7482490-8/1/1 29-Jun-2012 60MCA16 3006070239 Napp Pharmaceuticals Ltd. United Kingdom
 
112-7482490-8/1/2 29-Jun-2012 60MCA16 3006070239 Napp Pharmaceuticals Ltd. United Kingdom
 
344-0818912-3/1/1 12-Jun-2012 60PCS03 3005291439 Chemagis Israel
 
112-6676081-2/1/1 19-Jun-2012 60QAK99 3008276642 Pakmail Antonio Caso Mexico
 
AEK-0279092-7/1/3 05-Jun-2012 60QAO67 3009518610 Bunker Brasil Brazil
 
112-8385678-3/1/1 06-Jun-2012 60QCL84 3008468791 Instituto Seroterapico Peruano Peru
 
BER-4073619-9/1/1 06-Jun-2012 60QCS55 3002807824 BASF Pharma (Evionnaz) SA Switzerland
 
XXX-0223768-4/1/1 25-Jun-2012 60QDY40 3005308868 DFL INDUSTRIA E COMERCIO SA Brazil
 
071-0192206-5/3/22/E 19-Jun-2012 60SAU25 3002807920 Pharmaceutical Works Polpharma S.A. Poland
 
071-0192206-5/3/22/G 19-Jun-2012 60SBY99 3008089718 Bayer Poland
 
112-7374731-6/1/1 18-Jun-2012 60SIE99 3003516812 Patheon Inc. Canada
 
XXX-0178111-2/2/4 28-Jun-2012 60SML99 3004341688 P.A. Benjamin Manufacturing Co., Ltd. Jamaica
 
XXX-0178111-2/2/3 28-Jun-2012 60SML99 3004341688 P.A. Benjamin Manufacturing Co., Ltd. Jamaica
 
112-6659193-6/1/2 19-Jun-2012 60TCB99 3008274549 Andromaco Sa De Cv Mexico
 
MH9-0102292-0/1/1 13-Jun-2012 60WLR31 3009481658 Ningbo Hi-Tech Biochemicals Co Ltd China
 
WBA-9116223-9/1/1 19-Jun-2012 60WPS26 3010164006 Adani Pharmachem Private Limited India
 
523-0965815-2/1/1 07-Jun-2012 60WQT01 3009283902 Changzhou Yabang-Qh Pharmachem China
 
112-7129690-1/3/1 11-Jun-2012 60XCA17 3003989770 Cobalt Pharmaceuticals, Inc. Canada
 
334-2770570-3/1/1 11-Jun-2012 60XIR25 3004096632 Moehs Cantabra, S.L. Spain
 
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