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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-0177645-0/2/1/B 11-Jul-2013 56BCE03 3009400476 Lab Bailly Creat France
 
XXX-0177677-3/1/1/I 11-Jul-2013 56BCE03 3005035920 Caplin Point Laboratories Ltd India
 
XXX-0177807-6/2/1 11-Jul-2013 56BCE07 3008007437 Unknown Multiple Countries (PODS ONLY)
 
XXX-0177399-4/3/1/B 11-Jul-2013 56BCY03 3009402733 Sprukfield (U.K.) SARL United Kingdom
 
XXX-0177839-9/2/1 11-Jul-2013 56BCY05 3005099304 Ratio Sa Dominican Republic
 
XXX-0177399-4/3/1/C 11-Jul-2013 56ECY65 3009402733 Sprukfield (U.K.) SARL United Kingdom
 
112-2862227-6/1/1 01-Jul-2013 56EDR21 1000189256 Yangzhou Pharmaceutical Co., Ltd China
 
AEK-9240639-2/1/1 01-Jul-2013 56HYP45 3007518432 Accord Healthcare, Inc. United States
 
M21-0748439-8/1/1 29-Jul-2013 56JAA22 3010171011 Ncpc International Corp China
 
XXX-0177771-4/2/1 11-Jul-2013 56KCA99 3008007437 Unknown Multiple Countries (PODS ONLY)
 
UPS-0480828-5/1/1 24-Jul-2013 56YBK99 3006275277 Bismarck Premium Brands Gmbh Germany
 
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