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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 336-9956927-5/2/1


Manufacturer FEI1119657
Manufacturer NameBoehringer Ingelheim Chemicals Inc  
Manufacturer Address line 12820 Normandy Dr  
Manufacturer Address line 2  
Manufacturer's CityPetersburg  
Manufacturer Province/StateVA  
Manufacturer Country/AreaUnited States  
Product Code65QCS22  
Importer's Product DescriptionMETHOCARBAMOL USP  
Refusal Date05-Aug-2002  
FDA DistrictBLT-DO  
Entry/doc/line/sfx 336-9956927-5/2/1
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.  
INSANITARY   501(a)(2)(A), 801(a)(3); ADULTERATION   The article appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.  
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