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
HOC GUAN MANUFACTURING CORPORATION
MALABON PH-NOTA, PH 1470 NYK-DO KM6-0034174-7/8/1
24AEE16 TEMPLE BLACK BEAN
03-JAN-2008 NONRSP-VER
Erma Industries, Inc.
Navotas, Metro Manila PH-NOTA, PH 1485 SAN-DO D11-0112893-6/1/1
24TGN99 BITTERMELON LEAVES
07-JAN-2008 PESTICIDES
Guzent Inc
Quezon City , PH CHI-DO 805-0069133-4/13/1
21SGD14 FRESH FROZEN TAMARIND FRUIT WHOLE
10-JAN-2008 FILTHY
Zuellig Pharma
Makati , PH SAN-DO 112-0229680-5/1/1
62MDJ99 912072830046 TRIDDERM
10-JAN-2008 NOT LISTED
UNAPPROVED
Zuellig Pharma
Makati , PH SAN-DO 112-0229680-5/1/2
62MDJ99 912072830046 DIPROLENE
10-JAN-2008 NOT LISTED
UNAPPROVED
Pacific Isles International Trading Inc
Quzon City , PH SAN-DO BDD-0744905-7/8/1
16CGD99 FROZEN COOKED FISH FLAKES
10-JAN-2008 FILTHY
Zuellig Pharma
Makati , PH SAN-DO 112-0229680-5/1/3
62MDJ99 912072830046 DIPROLENE
10-JAN-2008 NOT LISTED
UNAPPROVED
Zuellig Pharma
Makati , PH SAN-DO 112-0229680-5/1/4
62MDJ99 912072830046 TERRAMYCIN
10-JAN-2008 NOT LISTED
UNAPPROVED
Uap Philippines
Novartes , PH SAN-DO 112-0252260-6/1/1
62GOY99 862824089254TENOXICAM 900 MG
10-JAN-2008 UNAPPROVED
Phil Pharmawealth Inc
Pasig City , PH SAN-DO 112-0510347-9/1/1
56BDE03 862823999621 AMOXICILLIN
10-JAN-2008 UNAPPROVED
Swiss Pharmaceutical Research
Laguna , PH SAN-DO 112-0510347-9/2/1
61PRA99 862823999621 DIACLID
10-JAN-2008 UNAPPROVED
Glaxo Phils. Inc
Makati, Pasong , PH 1231 SAN-DO 112-0575510-4/1/1
63BCH01 861302528917 VENTOLIN
10-JAN-2008 UNAPPROVED
Amherst Lab Inc
Manila , PH SAN-DO 112-0575510-4/3/1
62OCA41 861302528917 LIFEZAR
10-JAN-2008 UNAPPROVED
Edmond Pharma Srl
Manila , PH SAN-DO 112-0575510-4/3/2
66SCH27 861302528917 CARBIBLOC
10-JAN-2008 UNAPPROVED
United Laboratories
Mandaluyong , PH SAN-DO 112-0575510-4/3/3
65BCH03 861302528917 CARBOCYSTEINE
10-JAN-2008 UNAPPROVED
Interphil Lab Inc
Laguna , PH SAN-DO 112-0575510-4/4/1
64LCA56 861302528917 PREDISONE
10-JAN-2008 UNAPPROVED
Phil Pharmawealth Inc
Pasig City , PH SAN-DO 112-0665188-0/1/1
56BDC03 863371702867 AMOXICILLIN
10-JAN-2008 UNAPPROVED
Phil Pharmawealth Inc
Pasig City , PH SAN-DO 112-0665188-0/2/1
62GAH48 863371702867 MEFENAMIC
10-JAN-2008 UNAPPROVED
Phil Pharmawealth Inc
Pasig City , PH SAN-DO 112-0665188-0/3/1
62VAA18 863371702867 ZOVIRAX
10-JAN-2008 UNAPPROVED
Pfizer
Makati City , PH SAN-DO 112-0665188-0/4/1
62OCA04 863371702867 ACCUPRIL
10-JAN-2008 UNAPPROVED
Liwayway Marketing Corp
Imus Cavite, PH FLA-DO 561-0084692-4/1/6
03FYT08 RIBBED CRACKLINGS IN OLD FASHIONED SALT & VINEGAR
11-JAN-2008 UNSAFE COL
YELLOW #5
REGENT FOODS CORPORATION
PASIG CITY PH-NOTA, PH 1601 FLA-DO 561-0084692-4/4/1
24AEE60 SWEET CORN
11-JAN-2008 UNSAFE COL
Victorias Foods Corporation
Negros Occidental , PH FLA-DO 561-0084692-4/9/1
16AEE99 MILKFISH IN OIL
11-JAN-2008 NEEDS FCE
NO PROCESS
Aling Conching Native Products
Pampanga , PH LOS-DO BDD-0773503-4/2/1
25JGT23 DRIED TARO LEAVES
11-JAN-2008 SALMONELLA
Maunlad Canning Corp.
Metro Manila , PH SAN-DO AWL-0709024-7/31/1
16AEE33 SARDINES
15-JAN-2008 LIST INGRE
NUTRIT LBL
Chattrade Enterprises
Binondo, Manila , PH SAN-DO AWL-0709024-7/32/1
16MEE03 SQUID
15-JAN-2008 NEEDS FCE
NO PROCESS
Maunlad Canning Corp
Manila , PH SAN-DO 961-0042051-0/34/1
16AEE33 Sardines in Tomato Sauce
15-JAN-2008 LIST INGRE
NUTRIT LBL
Star Exports
Quezon City PH-ILN, PH 1116 SAN-DO 961-0042051-0/35/1
16MET03 SABA SQUID IN SOY SAUCE
15-JAN-2008 NEEDS FCE
NO PROCESS
Maunlad Canning Corp
Manila , PH SAN-DO 961-0042051-0/34/2
16AEE33 SARDINES IN TOMATO SAUCE WITH HOT CHILI
15-JAN-2008 LIST INGRE
NUTRIT LBL
Rdl Cosmetics Laboratory Inc
Davao City , PH SAN-DO AWL-0709024-7/36/10
63VCJ02 RDL HYDROQUINONE #2 & #3
16-JAN-2008 NOT LISTED
Intelligent Skin Care Inc
Pasig City , PH SAN-DO AWL-0709024-7/36/11B
66VBO99 BELO WHITENING LOTION SPF 15
16-JAN-2008 NOT LISTED
Greenstone Pharmaceuticals
Quezon City , PH SAN-DO AWL-0709024-7/43/1
62FBJ46 OINTMENT
16-JAN-2008 NOT LISTED
Greenstone Pharmaceuticals
Quezon City , PH SAN-DO AWL-0709024-7/43/2
62FBJ46 OIL
16-JAN-2008 NOT LISTED
Greenstone Pharmaceuticals
Quezon City , PH SAN-DO AWL-0709024-7/43/3
62FBJ46 PAIN MEDICINE
16-JAN-2008 NOT LISTED
Prcter & Gamble Phils Inc
Makati , PH SAN-DO 112-0832796-8/4/1
77K--CO 704213517709 VICKS NASAL INHALER
22-JAN-2008 NOT LISTED
Del Monte Philippines, Incorporated
Cagayan De Oro City PH-NOTA, PH 9000 SAN-DO 961-0042051-0/10/1
21AET01 FIESTA FRUIT COCKTAIL IN TIN CAN
22-JAN-2008 NO PROCESS
Del Monte Philippines, Incorporated
Cagayan De Oro City PH-NOTA, PH 9000 SAN-DO 961-0042051-0/10/2
21AET01 FIESTA FRUIT COCKTAIL IN TIN CAN
22-JAN-2008 NO PROCESS
Florence Foods Corporation
Manila , PH SAN-DO 961-0042051-0/31/1
24FGT08 CHILI PEPPER
22-JAN-2008 NO PROCESS
Star Exports
Quezon City PH-ILN, PH 1116 SAN-DO 961-0042051-0/33/1
24AEN51 COOKED DRY PEAS
22-JAN-2008 NO PROCESS
Rdl Cosmetics Laboratory Inc
Davao City , PH SAN-DO 961-0042051-0/40/17
66VBJ99 RDL HYDROQUINONE #2
22-JAN-2008 NOT LISTED
Rdl Cosmetics Laboratory Inc
Davao City , PH SAN-DO 961-0042051-0/40/18
66VBJ99 RDL HYDROQUINONE #3
22-JAN-2008 NOT LISTED
HDR FOODS CORPORATION
QUEZON , PH SAN-DO BDD-0744971-9/6/4
37JGT99 SWEET & SOUR SAUCE
22-JAN-2008 UNSAFE COL
LIST INGRE
Metro Drug
Bicutan , PH SAN-DO 112-0882560-7/5/1
62CDC10 863374502415 CLONIDINE (CATAPRESS)
23-JAN-2008 UNAPPROVED
United Laboratories Inc
Mandaluyong Metro Manila , PH 1550 SAN-DO 112-0882560-7/5/2
62ODC41 863374502415 LOSARTAN (LIFEZAR
23-JAN-2008 UNAPPROVED
Schering-Plough Corp.
Mandaluyong , PH SAN-DO 112-0882560-7/5/3
61JDC14 863374502415 VYTORIN EZETIMIBE SIMVASTAT
23-JAN-2008 UNAPPROVED
Janssen Pharmaceutica
Pasig , PH SEA-DO 112-0966250-4/1/1
60WOA16 862825911214 MEBENDAZOLE
30-JAN-2008 NEW VET DR
Sikat Araw Trading Corporation
Bacolod PH-NEC, PH 6110 LOS-DO 595-4376022-3/1/1
16MYY09 FROZEN OCTOPUS
30-JAN-2008 FILTHY
Jeverps Manufacturing
Metro Manila Rizal, PH LOS-DO 277-0116276-3/5/1
04YGT04 EXCELLENT RICE STICK NOODLES
31-JAN-2008 FILTHY
Ecco Food Corp.
Kaloocan City , PH SAN-DO AWL-0709024-7/14/1B
03JGT09 STRAWBERRY FLAVOR WAFER STICK
31-JAN-2008 UNSAFE COL
Del Monte
Cagayan De Oro City Ph-Nota, PH 9000 SAN-DO AWL-0709024-7/8/2
21AEE01 FRUIT COCKTAIL
31-JAN-2008 NO PROCESS
Del Monte
Cagayan De Oro City Ph-Nota, PH 9000 SAN-DO AWL-0709024-7/8/1
21AEE01 FRUIT COCKTAIL
31-JAN-2008 NO PROCESS