Refusal Actions by FDA as Recorded in OASIS for Philippines

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Tosen Food In. Quezon City , PH LOS-DO 555-0385178-8/12/1 24AET51 SENORITA DRY PEAS 04-AUG-2008 NEEDS FCE NO PROCESS San Miguel Corp Pasig Mtero Manila , PH LOS-DO 555-0384306-6/5/1 30JDT04 MAGNOLIA P. JUICE MANGO ORANGE 04-AUG-2008 COLOR LBLG LACKS N/C NUTRIT LBL YELLOW #5 San Miguel Corp Pasig Mtero Manila , PH LOS-DO 555-0384306-6/5/3 30JDT06 MAGNOLIA P. JUICE TEA LEMONADE 04-AUG-2008 LACKS N/C YELLOW #5 San Miguel Corp Pasig Mtero Manila , PH LOS-DO 555-0384306-6/5/4 30JDT02 MAGNOLIA P. JUICE PONKAN 04-AUG-2008 UNSAFE COL LACKS N/C YELLOW #5 San Miguel Corp Pasig Mtero Manila , PH LOS-DO 555-0384306-6/5/5 30JDT02 MAGNOLIA P. JUICE TEA LEMON 04-AUG-2008 LACKS N/C NUTRIT LBL San Miguel Corp Pasig Mtero Manila , PH LOS-DO 555-0384306-6/5/6 30JDT06 MAGNOLIA P. JUICE TEA MANGO 04-AUG-2008 LIST INGRE LACKS N/C NUTRIT LBL Diana Stalder Professional Skin Care Mandaluyong City , PH FLA-DO 606-0103170-5/7/1 66PBJ99 SUNBLOCK CREME 06-AUG-2008 UNAPPROVED Diana Stalder Professional Skin Care Mandaluyong City , PH FLA-DO 606-0103170-5/8/1 66PBJ99 Sunblock Gel 06-AUG-2008 NOT LISTED Karexx International Inc. Manila Rizal, PH LOS-DO K80-0954138-5/4/2 02HCT01 TAPIOCA IN SYRUP 12-AUG-2008 NEEDS FCE NO PROCESS FELICISIMO MARTINEZ & CO., INC ANTIPOLO PH-RIZ, PH 1870 LOS-DO BDD-0774324-4/3/1 07BGT99 EGG CRACKLET 13-AUG-2008 UNSAFE COL FELICISIMO MARTINEZ & CO., INC ANTIPOLO PH-RIZ, PH 1870 LOS-DO BDD-0774324-4/3/2 07BGT99 EGG CRACKLET 13-AUG-2008 UNSAFE COL Aling Conching Native Products Pampanga , PH LOS-DO BDD-0774227-9/1/1 02HGT01 TAPIOCA PEARL 13-AUG-2008 UNSAFE COL A & J Seafoods And Marine Products Santos , PH SAN-DO EBH-0061708-7/1/1 16AGD45 FRZN. TUNA CUBES 18-AUG-2008 LIST INGRE HISTAMINE FILTHY LACKS FIRM LACKS N/C USUAL NAME TRANSFAT Citra Mina Seafood Corporation Gen. Santos City PH-DAS, PH 9500 NYK-DO 594-0187398-5/2/1 16AGT45 FROZEN TUNA STEAK "AHI" Partial Refusal 26-AUG-2008 FILTHY Universal Robina Corporation Quezon City Manila, PH SAN-DO EBH-0061991-9/41/1 62GAL99 Green Tea (Apple Flavor) 26-AUG-2008 NOT LISTED DRUG NAME UNAPPROVED Universal Robina Corporation Quezon City Manila, PH SAN-DO EBH-0061991-9/42/1 62GAL99 Green Tea (Lemon Flavor) 26-AUG-2008 NOT LISTED DRUG NAME UNAPPROVED Cosmetic Asia Bulacan , PH SAN-DO EBH-0061991-9/49/1 63VAX99 Whitening Herbal Soap 26-AUG-2008 NOT LISTED DRUG NAME UNAPPROVED Interphil Lab Inc Laguna , PH SAN-DO EBH-0061991-9/51/1 66VDL99 Vaginal Antiseptic Solution 26-AUG-2008 NOT LISTED DRUG NAME Dyson Laboratories Makati City , PH SAN-DO EBH-0061991-9/52/1 66VBU99 Papaya Plus Whitening Soap 26-AUG-2008 NOT LISTED DRUG NAME UNAPPROVED Procter & Gamble Philippine Manufacturing Corp Makati Metro Manila , PH SAN-DO EBH-0061991-9/54/1A 61HBJ05 Rejoice Complete Shampoo 26-AUG-2008 NOT LISTED