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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 is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies. [Adulteration, Section 501(a)(5)]  
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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