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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
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
XXX-0286424-8/1/1 14-Jun-2012 56ACZ10 3006216965 Sandoz Australia
 
112-9655341-9/1/1 01-Jun-2012 56BCB03 3000327587 Pfizer Italiana Italy
 
112-9655341-9/1/2 01-Jun-2012 56BCB03 3002807084 GlaxoSmithKline Manufacturing S.p.A. Italy
 
XXX-0286383-6/1/12 12-Jun-2012 56BCE03 3006647289 Roemmers S.A.I.C.F. Argentina
 
112-5596523-2/1/1 20-Jun-2012 56BCE03 3003967026 Pfizer Venezuela
 
XXX-0286383-6/1/8 12-Jun-2012 56BCF03 3005076800 Corporacion Bonima, S.A. El Salvador
 
XXX-0286443-8/1/3 19-Jun-2012 56BCF03 3006743483 Cipla India
 
XXX-0286443-8/1/2 19-Jun-2012 56BCF05 3006743483 Cipla India
 
112-7520037-1/1/1/B 29-Jun-2012 56BDA03 3004501995 Productos Maver, S.A. de C.V. Mexico
 
T94-0057400-8/1/1 29-Jun-2012 56BYY19 3006078658 Penam Labaratories Limited India
 
112-7256692-3/1/4 11-Jun-2012 56CCA99 3008403508 Mylan Sas France
 
112-6013763-7/1/1 18-Jun-2012 56CYY69 3008179934 Toku-E China
 
112-7483187-9/1/1 29-Jun-2012 56DCP20 3009530123 Douglas Rosales Venezuela
 
112-6021260-5/3/1 15-Jun-2012 56ECA20 3006186850 Dexon Ltd Israel
 
112-6812082-5/1/1 20-Jun-2012 56ECA99 1000476214 Mead Johnson De Mexico/Bristol Myers de Mexico S.A. de C.V. Mexico
 
112-5902031-6/1/1 15-Jun-2012 56ECB20 3009338966 Accis Ltd Cyprus
 
XXX-0286443-8/1/4 19-Jun-2012 56ECF99 3006765693 Laboratorios Quifarma, S.A. Guatemala
 
XXX-0238486-6/1/2 25-Jun-2012 56EDY65 1000586920 Pfizer Brazil
 
112-6597696-4/1/1 19-Jun-2012 56FYY99 3007554486 GL Biochem (Shanghai) Ltd China
 
XXX-0178111-2/2/1 28-Jun-2012 56GBL99 3004341688 P.A. Benjamin Manufacturing Co., Ltd. Jamaica
 
U47-0490915-7/4/1 01-Jun-2012 56GDO50 3008378791 Lubnypharm Ukraine
 
112-6630645-9/1/1 18-Jun-2012 56ICA76 3002173302 Pfizer Pharmaceuticals LLC United States
 
112-7047226-3/1/1 08-Jun-2012 56IYY99 3006763264 Henan Topfond Pharmaceutical Co., Ltd. China
 
112-1774412-2/1/1 04-Jun-2012 56JAO31 3003695001 Hoe Pharmaceuticals Malaysia
 
231-3763380-0/1/1 25-Jun-2012 56JCK31 3000314035 Pharmacia & Upjohn Worldwide United States
 
112-1021674-8/1/1 04-Jun-2012 56OXK05 3005909349 Invesa Industrial Veterinaria, S.A. Spain
 
U47-0490915-7/11/1 01-Jun-2012 56YCK99 3002807460 LEK Pharmaceuticals dd Slovenia
 
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