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
Unilever Foods Philippines-Cavite
Cavite PH-CAV, PH 4107 SEA-DO EH5-0041452-7/35/1
16ACE45 LADYS CHOICE TUNA SPREAD BIG
02-JUN-2008 TRANSFAT
NEEDS FCE
NO PROCESS
Farmland Processing And Manufacturing Corp
Makati City , PH SEA-DO EH5-0041452-7/36/1
16AET45 LADY'S CHOICE TUNA SPREAD SMALL
02-JUN-2008 NEEDS FCE
NO PROCESS
Farmland Processing And Manufacturing Corp
Makati City , PH SEA-DO EH5-0041452-7/39/1
16AET45 CENTURY TUNA MECHADO
02-JUN-2008 NEEDS FCE
NO PROCESS
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO J14-0060048-9/80/1A
66PAJ99 B&W Radiance lotion SPF 20
04-JUN-2008 UNAPPROVED
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO J14-0060048-9/80/1B
66PAJ99 B&W Milk Classic
04-JUN-2008 NOT LISTED
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO J14-0060048-9/80/1C
66PAJ99 B&W Ultima lotion SPF 20
04-JUN-2008 UNAPPROVED
Ecco Food Corp.
Kaloocan City , PH SAN-DO J14-0060048-9/47/1B
03JHT09 STICK O STRAWBERRY
04-JUN-2008 UNSAFE COL
LIST INGRE
Ecco Food Corp.
Kaloocan City , PH SAN-DO J14-0060048-9/47/1C
03JHT09 STICK O UBE
04-JUN-2008 UNSAFE COL
LIST INGRE
Gem Food Products, Inc.
Laguna , PH SAN-DO 478-0215322-2/10/1
21SGD14 FOZEN BUENAS TAMARIND FRUIT
05-JUN-2008 FILTHY
Evergreen Enterprises
Santos City , PH FLA-DO 605-4057387-4/1/1
16AVD45 FROZEN TUNA LOIN CENTER CUT
09-JUN-2008 FILTHY
Pfizer, Inc.
Makati City , PH CIN-DO UPS-1070036-5/1/1
65KCA09 CYTOTEC 200MG, NO RX, NO ID, PER USE
10-JUN-2008 UNAPPROVED
Alenter Food Inc
Mandaue City , PH LOS-DO 178-0083540-1/5/1
16CCE53 SMOKED BANGUS IN CORN OIL
12-JUN-2008 NEEDS FCE
NO PROCESS
Alenter Food Inc
Mandaue City , PH LOS-DO 178-0083540-1/5/2
16CCE53 BANGUS PATE
12-JUN-2008 NEEDS FCE
NO PROCESS
Alenter Food Inc
Mandaue City , PH LOS-DO 178-0083540-1/6/1
16GCE02 SMOKED ALMEJAS IN OLIVE OIL
12-JUN-2008 NEEDS FCE
NO PROCESS
Alenter Food Inc
Mandaue City , PH LOS-DO 178-0083540-1/7/1
16PCE03 CHIPIRONES EN SU TINTA IN OLIVE OIL
12-JUN-2008 NEEDS FCE
NO PROCESS
Alenter Food Inc
Mandaue City , PH LOS-DO 178-0083540-1/8/1
16CCE21 DRIED HERRING WITH GARLIC IN OLIVE OIL
12-JUN-2008 NEEDS FCE
NO PROCESS
Alenter Food Inc
Mandaue City , PH LOS-DO 178-0083540-1/9/1
16YCE12 SAUTEED SHRIMP (SWEET)
12-JUN-2008 NEEDS FCE
NO PROCESS
Tianjin Medicines & Health Produ
Makati City , PH SAN-DO 112-2693226-0/1/1
64LCO28 865143451886 FLUOCINONIDE
16-JUN-2008 NOT LISTED
Merck Sharp & Dohme Phils
Makati City , PH SAN-DO 112-2795424-8/1/1
64UCY06 865143331403 FINASTERIDE
16-JUN-2008 NOT LISTED
A&J Seafoods & Marine Products
General Santos City , PH SAN-DO 427-7303542-5/1/1
16AGD53 FROZEN TUNA CUBES
23-JUN-2008 FILTHY
TRANSFAT
Citra Mina Seafood Corporation
Gen. Santos City PH-DAS, PH 9500 LOS-DO 082-0302092-3/1/2
16AGT45 FRZ. YELLOWFIN TUNA STEAK STYLE 4OZ 6OZ 8OZ
24-JUN-2008 FILTHY
Citra Mina Seafood Corporation
Gen. Santos City PH-DAS, PH 9500 LOS-DO 082-0302092-3/1/3
16AGT45 FRZ. YELLOWFIN TUNA SAKU MEDIUM, LARGE
24-JUN-2008 FILTHY
Citra Mina Seafood Corporation
Gen. Santos City PH-DAS, PH 9500 LOS-DO 082-0302092-3/1/1
16AGT45 FRZ. YELLOWFIN TUNA POKE CUBES
24-JUN-2008 FILTHY
Pacific Isles International Trading Inc
Quzon City , PH LOS-DO HK1-0177537-5/4/1
16YCP03 LINGAYEN SALTED ANCHOVY PASTE
25-JUN-2008 FILTHY
REGENT FOODS CORPORATION
PASIG CITY PH-NOTA, PH 1601 NYK-DO AK9-0030613-0/13/2
07BGT02 REGENT CORN FLAVOURED CHIPS
27-JUN-2008 UNSAFE COL
Unilever Foods Philippines-Cavite
Cavite PH-CAV, PH 4107 LOS-DO 555-0383906-4/2/1
27YCT07 BEST FOOD SANDWICH SPREAD
30-JUN-2008 NEEDS FCE
NO PROCESS