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
Dole Philippines Corp.
Paranaque City , PH LOS-DO 555-0384306-6/1/1
21VET05 SEASONS MANGO JUICE DRINK
01-JUL-2008 NEEDS FCE
NO PROCESS
Pfizer
Metro Manila , PH NOL-DO 112-0948878-5/1/1
56JCF99 CLINDAMYCIN
02-JUL-2008 UNAPPROVED
Essex Pharma Inc
Mandaluyongs , PH SAN-DO 112-2478029-9/1/1
64LAO37 864540361272 CORTASONE CREAM
02-JUL-2008 NOT LISTED
UNAPPROVED
Edlou Enterprises
Manila PH-ILS, PH 1008 SAN-DO D11-0115006-2/7/9
16AGH73 DRIED MAKCEREL
07-JUL-2008 HISTAMINE
Philippnie Cinmic Indistrial Corp.
General Santos City , PH LOS-DO EML-0100694-3/1/1
16AGD45 FRAN TUNA SAKU
08-JUL-2008 FILTHY
Philippnie Cinmic Indistrial Corp.
General Santos City , PH LOS-DO EML-0100694-3/1/2
16AGD45 FRZN TUNA GROUND MEAT
08-JUL-2008 HISTAMINE
Pfizer Phils
Makati City , PH SAN-DO 112-3098065-1/1/1
62OCA24 848082203067 DILTIAZEM
10-JUL-2008 NOT LISTED
Abegail S. Syparrado
Mandaue Citymandaue City , PH 6014 CIN-DO UPS-1494783-0/3/1
66VCA99 AMOXICILLIN 500MG, NO RX, NO ID, US CUSTOMS DENIED ENTRY
11-JUL-2008 UNAPPROVED
Abegail S. Syparrado
Mandaue Citymandaue City , PH 6014 CIN-DO UPS-1494783-0/3/2
66VCA99 PHENYLPROPANOLAMINE, NO RX, NO ID, US CUSTOMS DENIED ENTRY
11-JUL-2008 UNAPPROVED
Mofel'S Food International
Metro Manila , PH SEA-DO EH5-0041785-0/3/1
25JET02 Taro Leaves
11-JUL-2008 FILTHY
FALSE
TRANSFAT
Mofel'S Food International
Metro Manila , PH SEA-DO EH5-0041785-0/2/1
25JET02 Taro Leaves
11-JUL-2008 FILTHY
FALSE
TRANSFAT
Spi Corporation
Canlubang Calamba , PH 4027 SEA-DO EH5-0041785-0/31/1
03HFT08 STARR CANDY ORANGE
11-JUL-2008 UNSAFE COL
FALSE
USUAL NAME
Spi Corporation
Canlubang Calamba , PH 4027 SEA-DO EH5-0041785-0/32/1
03HFT08 STARR CANDY MELON DEWS
11-JUL-2008 UNSAFE COL
FALSE
USUAL NAME
Spi Corporation
Canlubang Calamba , PH 4027 SEA-DO EH5-0041785-0/33/1
03HFT08 STARR CANDY HONEY LEMON
11-JUL-2008 UNSAFE COL
FALSE
USUAL NAME
Spi Corporation
Canlubang Calamba , PH 4027 SEA-DO EH5-0041785-0/34/1
03HFT08 STARR CANDY EUCALYPLUS
11-JUL-2008 FALSE
USUAL NAME
TBN FOOD PRODUCTS
Tanauan PH-BTG, PH 4232 LOS-DO BDD-0774010-9/6/3
66VBL99 LACTOSERUM LACTIC ACID
16-JUL-2008 UNAPPROVED
TBN FOOD PRODUCTS
Tanauan PH-BTG, PH 4232 LOS-DO BDD-0774010-9/7/1
53DD-01 MILK WHITENING ROLL-ON DEODORANT & ANTI-PERSPIRANT
16-JUL-2008 UNAPPROVED
TBN FOOD PRODUCTS
Tanauan PH-BTG, PH 4232 LOS-DO BDD-0774010-9/7/3
66VBL99 DEODORANT ROLL-ON(FLOWER BATH)
16-JUL-2008 UNAPPROVED
TBN FOOD PRODUCTS
Tanauan PH-BTG, PH 4232 LOS-DO BDD-0774010-9/7/6
66VBU99 MILK WHITENING SOAP
16-JUL-2008 UNAPPROVED
TBN FOOD PRODUCTS
Tanauan PH-BTG, PH 4232 LOS-DO BDD-0774010-9/9/1
66VBL99 OMEGA PAIN KILLER LINIMENT
16-JUL-2008 UNAPPROVED
Marigold Commodities Corp (plant)
San Juan (Metro Manila) , PH SWI-DO AX0-0022063-6/1/3
21TYT14 TAMARIND PASTE (BIGLANG SINIGANG) REGULAR
17-JUL-2008 FILTHY
Marigold Commodities Corp (plant)
San Juan (Metro Manila) , PH SWI-DO AX0-0022063-6/1/4
37JVY99 TAMARIND PASTE (BIGLANG SINIGANG) HOT
17-JUL-2008 FILTHY
Rdl Pharmaceutical Lab Inc.
Buhangin Davao , PH SAN-DO D11-0115036-9/23/2
66VDY99 RDL Papaya Whitening Soap
23-JUL-2008 NOT LISTED
DRUG NAME
UNAPPROVED
D'World 2000 Enterprises Corporation
Quezon PH-NOTA, PH 1104 SAN-DO D11-0115036-9/23/1
66VDY99 Papaya Skin Whitening Herbal Soap
23-JUL-2008 NOT LISTED
DRUG NAME
UNAPPROVED
Santa Cruz Trading
Gen. Santos City , PH 9500 SAN-DO D11-0115030-2/3/3
16AGT45 CO Treated Yellowfin Tuna Cubes (Random, Grade A Cut)
28-JUL-2008 FILTHY
Liwayway Marketing Corp
Imus Cavite, PH LOS-DO BDD-0774223-8/7/2
07BGT02 OISHI BEER MATCH-SALT & VINEGAR(SNACKS)
29-JUL-2008 UNSAFE COL
Marigold Commodities Corp (plant)
San Juan (Metro Manila) , PH FLA-DO BLZ-3015480-4/5/1
37JCT02 BARBECUE MARINADE SAUCE
31-JUL-2008 NEEDS FCE
NO PROCESS
Barro Fiesta Manufacturing Inc
Pasig City , PH FLA-DO BLZ-3015480-4/6/1
16YCT12 SALTED SHRIMP FRY
31-JUL-2008 NEEDS FCE
NO PROCESS
Sharmila, Inc.
Paco , PH FLA-DO BLZ-3015480-4/23/1
16ACT33 MILKFISH IN CORN OIL
31-JUL-2008 NEEDS FCE
NO PROCESS
Sharmila, Inc.
Paco , PH FLA-DO BLZ-3015480-4/24/1
16ACT33 SPANISH SARDINES
31-JUL-2008 NEEDS FCE
NO PROCESS
7 D International
Cebu , PH FLA-DO BLZ-3015480-4/27/1
21RGT05 MANGO PUREE
31-JUL-2008 NEEDS FCE
NO PROCESS