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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 56-Antibiotics (Human/Animal)

Entry/doc/line/sfx Refusal Date Product
FP1-0008186-7/3/1 12-Oct-2012 56BCH03 3003964996 Athlone Laboratories Ltd Ireland
XXX-0244631-9/1/4 09-Oct-2012 56BCY03 3005549631 Fardel El Salvador
XXX-0244287-0/1/4 09-Oct-2012 56BCY03 3005632939 Laboratories La Sante Colombia
XXX-0262480-8/1/5 15-Oct-2012 56BCY03 3006948036 Caplin Point Lab Ltd India
XXX-0262480-8/1/6 15-Oct-2012 56BCY07 3006948036 Caplin Point Lab Ltd India
FP1-0008186-7/9/1 12-Oct-2012 56BCY10 3009516424 Sandoz Gmbh / Genus Pharmaceuticals United Kingdom
M21-0746765-8/4/1 17-Oct-2012 56CCA11 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
XXX-0244287-0/1/8 09-Oct-2012 56DDY41 3005783926 Gonher Farmaceutica Colombia
XXX-0244631-9/1/5 09-Oct-2012 56ECY80 3005076800 Corporacion Bonima, S.A. El Salvador
AEK-0458162-1/1/1 26-Oct-2012 56EYY22 3002806351 Hikma Pharmaceuticals Co. Ltd Jordan
112-9063821-7/1/1 23-Oct-2012 56GAY20 3009703485 Chifeng Alpax Pharmaceutical Tech Co. Ltd. China
112-9828987-2/1/1 22-Oct-2012 56HDR45 3007719313 Zhejiang Hisun Pharmaceutical Co., Ltd. China
336-7407053-1/1/1 05-Oct-2012 56HIK24 3003411194 Tty Biopharm Co Taiwan
FP1-0008186-7/17/1 12-Oct-2012 56ICA10 3002806345 Aesica Queenborough Limited United Kingdom
XXX-0244287-0/1/17 09-Oct-2012 56ICY76 3005325017 La Sante Colombia
FP1-0008186-7/10/1 12-Oct-2012 56KCY10 3001116953 Actavis Italy S.p.A. Italy
112-9719915-5/1/1 24-Oct-2012 56OXY05 1000177994 Zhejiang Hua Sheng China
FP1-0008186-7/24/1 12-Oct-2012 56YDL99 3002807114 GlaxoSmithKline Manufacturing S.p.A. Italy
BUP-2531531-1/1/1 10-Oct-2012 56YIS99 3002807208 Hovione FarmaCiencia SA Portugal