Refusal Actions by FDA as Recorded in OASIS


   Country of Origin                     Entry #   DOC  Line Suffix
   Manufacture Name
   City / Country or region                                 District
   Product Code        Product Description
                          Date                              Reason
Mexico UPS-1363504-8 1 1 Central Alberta Compounding Centre Red Deer AB, CA CIN-DO 64GIK08 ESTRADIOL BENZOATE, INJECTIBLE SOLUTION, FDA NEEDED TO ABAND 11-JUL-2008 DRUG GMPS UNAPPROVED Mexico UPS-1363504-8 1 2 Central Alberta Compounding Centre Red Deer AB, CA CIN-DO 64GIK99 ESTRADIOL PROGESTERONE, INJECTIBLE SOLUTION, FDA NEEDED TO A 11-JUL-2008 DRUG GMPS UNAPPROVED Egypt 112-1052636-7 1 1 Novartis Pharma Obor City , EG NOL-DO 64LAJ60 861144799868 KINACORT CREAM 01-JUL-2008 UNAPPROVED Egypt 112-1052636-7 1 2 Novartis Pharma Obor City , EG NOL-DO 64LAJ67 861144799868 DERMOVATE CREAM 01-JUL-2008 UNAPPROVED Italy XXX-0154562-4 1 1 A Beltapharm S.p.A. Milan , IT unknown SWI-DO 64LAJ67 Fashion Fair Cream 07-JUL-2008 DIRECTIONS UNAPPROVED Germany XXX-0154562-4 1 1 B Scanchemie Ltd. Unknown , DE SWI-DO 64LAJ67 Hyprogel 07-JUL-2008 DIRECTIONS UNAPPROVED Nigeria XXX-0154562-4 1 1 C Orange Drugs Ltd Lagos , NG SWI-DO 64LAJ67 Neutrotone Cream 07-JUL-2008 DIRECTIONS UNAPPROVED Indonesia XXX-0154562-4 1 1 D PT. Tempo Scan Pacific Jakarta , ID SWI-DO 64LAJ67 Tempovate Gel 07-JUL-2008 DIRECTIONS UNAPPROVED Saudi Arabia XXX-0154562-4 1 1 E Glaxo Saudi Arabia Ltd. Unknown , SA SWI-DO 64LAJ67 Dermovate 07-JUL-2008 DIRECTIONS UNAPPROVED Philippines 112-2478029-9 1 1 Essex Pharma Inc Mandaluyongs , PH SAN-DO 64LAO37 864540361272 CORTASONE CREAM 02-JUL-2008 NOT LISTED UNAPPROVED Italy XXX-0154239-9 1 1 E Medical Chemical Agency San Vittore Olona MI, IT 20028 SWI-DO 64LCJ28 Top Gel 07-JUL-2008 DIRECTIONS UNAPPROVED Italy XXX-0154941-0 1 1 B Medical and Chemical Agency S.p.A. Milano MI, IT 20149 SWI-DO 64LCJ28 Top-Gel 24-JUL-2008 UNAPPROVED Italy XXX-0154941-0 1 1 A Esapharma S.R.L. Milano MI, IT 20134 SWI-DO 64LCJ67 Esapharma Movate 24-JUL-2008 UNAPPROVED Italy XXX-0154562-4 1 1 F Beltapharm S.p.A. Milan , IT unknown SWI-DO 64LDJ06 Fashion Fair Gel Plus 07-JUL-2008 DIRECTIONS UNAPPROVED Italy XXX-0154239-9 1 1 A Esapharma S.R.L. Milano MI, IT 20134 SWI-DO 64LDJ67 Movate Cream 07-JUL-2008 DIRECTIONS UNAPPROVED Italy XXX-0154239-9 1 1 B vitus pharm co ltd milan , IT SWI-DO 64LDJ67 Aloe Vera Cream with Clobeatsol Propionate 07-JUL-2008 DIRECTIONS UNAPPROVED China UPS-1554191-3 1 5 Xian Jintailan Art Shop Xi'Anxi'An , CN 710054 CIN-DO 64TCY99 DIACEREIN 07-JUL-2008 NOT LISTED DIRECTIONS China M21-0738095-0 1 1 Research Pharmaceutical Co Ltd Shanghai , CN FLA-DO 64XBR06 ACETYL SALICYLIC ACID FOR EXPORT ONLY, PLEASE REFUSE CARGO 08-JUL-2008 NOT LISTED Nigeria XXX-0154239-9 1 1 C Johnson Wax Nigeria, LTD Lagos , NG SWI-DO 64XDO03 Nixoderm 07-JUL-2008 DIRECTIONS UNAPPROVED Nigeria XXX-0154239-9 1 1 D Johnson Wax Nigeria, LTD Lagos , NG SWI-DO 64XDO03 Nixoderm 07-JUL-2008 DIRECTIONS UNAPPROVED