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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 101-7058563-1/1/1


Manufacturer FEI3007692005
Manufacturer NameBoehringer Ingelheim Pharma GMBH & Co  
Manufacturer Address line 1Binger Street 173, Ingelheim  
Manufacturer Address line 2  
Manufacturer's CityIngelheim  
Manufacturer Province/StateDE-RP  
Manufacturer Country/AreaGermany  
Product Code60CCS32  
Importer's Product DescriptionEPINEPHRINE HYDROGENTARTRATE  
Refusal Date22-Sep-2006  
FDA DistrictBLT-DO  
Entry/doc/line/sfx 101-7058563-1/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
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