Refusal Actions by FDA as Recorded in OASIS for Nigeria
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Evans Medical PLC
Agbara , NG SWI-DO 512-1004989-9/30/1
75L--FR Evans Glucose D
05-AUG-2008 UNAPPROVED
J.C. Udeozor and Sons
Unknown , NG SWI-DO 512-1004989-9/34/1
55PY-97 ABONIKI BALM
05-AUG-2008 UNAPPROVED
Mentholatum Nigeria Limited
Kona , NG SWI-DO 512-1004989-9/35/1
53LY-01 MENTHOLAUM BALM
05-AUG-2008 UNAPPROVED
PZ Nigeria Limited
Lagos Ng-La, NG None SWI-DO 512-1004989-9/36/1
53LY-01 HEATOL BALM
05-AUG-2008 UNAPPROVED
PZ Cussons Industries (Ghana) Ltd.
Tema , NG SWI-DO 512-1004989-9/37/1
53LY-01 ROBB BALM
05-AUG-2008 UNAPPROVED
R.K. Assiamah, M.H.P.A. Lond.
Kumasi , NG SWI-DO 512-1004989-9/53/1A
24UYT99 Dr R.K. Assiamahs Bitters
05-AUG-2008 UNAPPROVED
Tura International Ltd
London , GB LOS-DO HD8-0089119-8/1/1A
66PBJ09 Skin Toning Cream
05-AUG-2008 NOT LISTED
UNAPPROVED
VINCO PHARMACEUTICAL
MILAN , IT LOS-DO HD8-0089119-8/1/1B
64LAJ67 Topifram Cream
05-AUG-2008 NOT LISTED
UNAPPROVED
Beltapharm S.p.A.
Milan , IT unknown LOS-DO HD8-0089119-8/1/1C
64LAJ67 Fashion Fair Cream (Clobetasol Propionate)
05-AUG-2008 NOT LISTED
UNAPPROVED
Patheon Inc. - Toronto Region Operations
Mississauga Ontario, CA L5N 7K9 LOS-DO HD8-0089119-8/1/1D
64LDJ45 Acne Lotion
05-AUG-2008 NOT LISTED
UNAPPROVED
PZ Nigeria Limited
Lagos Ng-La, NG None LOS-DO HD8-0089119-8/1/1E
60LBJ07 Muscle Ache Ointment
05-AUG-2008 NOT LISTED
UNAPPROVED
Vinco Pharmaceuticals
UNKNOWN , GB LOS-DO HD8-0089119-8/1/1F
63VBL02 Lightening Body Oil
05-AUG-2008 NOT LISTED
UNAPPROVED
Vinco Pharmaceuticals
UNKNOWN , GB LOS-DO HD8-0089119-8/1/1G
64ABY19 Sivoclair Medicated Soap
05-AUG-2008 NOT LISTED
UNAPPROVED
Elliot Irving Ltd.
Glasgow , GB G37PR LOS-DO HD8-0089119-8/1/1H
56YDY99 Crusader Medicated Soap (w Potassium Mercuric Iodide)
05-AUG-2008 NOT LISTED
UNAPPROVED
Tura International Ltd.
Aba , NG LOS-DO HD8-0089119-8/1/1I
64ABY19 Germicidal Soap
05-AUG-2008 NOT LISTED
UNAPPROVED
Jagal Pharma Limited
Lagos , NG LOS-DO HD8-0089119-8/1/1J
66VBY99 Tetmosol Medicated Soap
05-AUG-2008 NOT LISTED
UNAPPROVED
VINCO PHARMACEUTICAL
MILAN , IT LOS-DO HD8-0089119-8/1/2A
64LDJ06 Betamethasone Dipropionate Gel
05-AUG-2008 NOT LISTED
UNAPPROVED
MCA Medical And Chemical Agency S.R.L.
San Vittore Olona MI, IT 20028 LOS-DO HD8-0089119-8/1/2B
64LDJ28 Fluocinonide Gel
05-AUG-2008 NOT LISTED
UNAPPROVED
MCA Medical And Chemical Agency S.R.L.
San Vittore Olona MI, IT 20028 LOS-DO HD8-0089119-8/1/2C
64LDJ28 Fluocinonide Gel Plus w/ Neomycin
05-AUG-2008 UNAPPROVED
Beltapharm S.p.A.
Milan , IT unknown LOS-DO HD8-0089119-8/1/2D
64LDJ06 Fashion Fair Gel Plus (Betamethasone dipropionate)
05-AUG-2008 UNAPPROVED
VINCO PHARMACEUTICAL
MILAN , IT LOS-DO HD8-0089119-8/1/2E
64LDJ06 Topifram Gel Plus (Betamethasone Dipropionate)
05-AUG-2008 UNAPPROVED
LABORATE
panipat 132 103 , IN LOS-DO HD8-0089119-8/1/2F
64LDJ08 Clear Skin gel (Betamethasone Valerate Gel)
05-AUG-2008 UNAPPROVED
Adis Ltd.
Hertford , GB SWI-DO U72-0513865-5/5/1
76E--FW TOOTHBRUSHES
26-AUG-2008 NOT LISTED
REGISTERED
NIGERIAN BOTTLING COMPANY
LAGOS NG-FC, NG NONE SWI-DO U72-0513865-5/14/1A
29BCO99 Fanta soft drink
26-AUG-2008 UNSAFE COL
COLOR LBLG
LABELING
NUTRIT LBL
PZ Nigeria Limited
Lagos Ng-La, NG None SWI-DO U72-0513865-5/26/1A
66VAR99 Medicated Dusting Powder
26-AUG-2008 UNAPPROVED