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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 582-5025723-5/1/1


Manufacturer FEI3003741647
Manufacturer NamePrudential Pharmaceuticals Ltd  
Manufacturer Address line 1Sy No 133 Ida Bolfaram Jinnaram Man  
Manufacturer Address line 2  
Manufacturer's CityNedak Dist  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code65QDA22  
FDA Product DescriptionMETHOCARBAMOL (RELAXANT)  
Refusal Date30-Aug-2002  
FDA DistrictDET-DO  
Entry/doc/line/sfx 582-5025723-5/1/1
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.  
NEW VET DR   501(a)(5), 801(a)(3); ADULTERATION   The article appears to be a new animal drug which is unsafe within the meaning of Section 512(a) in that there is not in effect an approval of an applications filed with respect to its intended use or uses.  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
RXCOMPOUND   503(b)(4)(A) & 502(c), 801(a)(3); MISBRANDING   the labeling fails to bear, at a minimum, the symbol "Rx only."  
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