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
Integrated Manila Asia Trading Corperation
Metro Manila , PH LOS-DO 880-0064555-1/8/1
33EGT06 STORK STARR CANDY
02-NOV-2007 POISONOUS
HOC GUAN MANUFACTURING CORPORATION
MALABON PH-NOTA, PH 1470 LOS-DO 880-0064710-2/11/1
24AGT16 SALTED BLACK BEANS
02-NOV-2007 UNDER PRC
International Pharmaceutical Inc
Cebu City Cebu, PH SAN-DO 112-8496834-6/1/1
60LDJ34 862832145392 PAIN RELIEVER
05-NOV-2007 NOT LISTED
UNAPPROVED
Coca Cola Bottlers Philippines Inc
Makati, Metro Manila , PH LOS-DO 555-0380361-5/13/1
29BET02 ROYAL TRU ORANGE (CAN)
07-NOV-2007 UNSAFE COL
COLOR LBLG
LACKS FIRM
LACKS N/C
Coca Cola Bottlers Philippines Inc
Makati, Metro Manila , PH LOS-DO 555-0380361-5/13/2
29BCT02 ROYAL TRU ORANGE (BOTTLE)
07-NOV-2007 LIST INGRE
COLOR LBLG
LACKS FIRM
LACKS N/C
USUAL NAME
Coca Cola Bottlers Philippines Inc
Makati, Metro Manila , PH LOS-DO 555-0380361-5/13/3
29BHT02 ROYAL TRU ORANGE (PET)
07-NOV-2007 UNSAFE COL
LIST INGRE
COLOR LBLG
LACKS FIRM
LACKS N/C
USUAL NAME
Phild Inc
Karasuma-Dori , JP 6048152 LOS-DO 510-7826370-7/3/1B
80L--DQ PHITEN RAKUWA BRACELET S TYPE (USA) (ITEM XTB94011
07-NOV-2007 REGISTERED
NO 510(K)
Phild Inc
Karasuma-Dori , JP 6048152 LOS-DO 510-7826370-7/3/1C
80L--DQ PHITEN RAKUWA NECKLACE s type (item 0212 XTb86013).
07-NOV-2007 REGISTERED
NO 510(K)
Citra Mina Seafood Corporation
Gen. Santos City PH-DAS, PH 9500 NYK-DO 594-0178608-8/1/1
16AGD45 FROZEN YF TUNA KT STEAK STYLE 6-8
Partial Refusal 13-NOV-2007 FILTHY
Citra Mina Seafood Corporation
Gen. Santos City PH-DAS, PH 9500 NYK-DO 594-0178608-8/1/2
16AGD45 FROZEN YF TUNA KT STEAK STYLE 10-12
13-NOV-2007 FILTHY
Citra Mina Seafood Corporation
Gen. Santos City PH-DAS, PH 9500 NYK-DO 594-0178608-8/1/3
16AGD45 FROZEN YF TUNA STEAK STYLE 10-12
Partial Refusal 13-NOV-2007 FILTHY
Citra Mina Seafood Corporation
Gen. Santos City PH-DAS, PH 9500 NYK-DO 594-0178608-8/1/4
16AGD78 FROZEN YF WAHOO KT WAHOO PORTION 6-8
13-NOV-2007 FILTHY
Citra Mina Seafood Corporation
Gen. Santos City PH-DAS, PH 9500 NYK-DO 594-0178608-8/1/5
16AGD78 FROZEN YF WAHOO KT WAHOO PORTION 10-12
13-NOV-2007 FILTHY
Alliance Tuna International, Inc.
Pasig City , PH SEA-DO 605-6508900-4/1/1
16AEE45 CANNED CHUNK LIGHT TUNA IN WATER
13-NOV-2007 FILTHY
Alliance Tuna International, Inc.
Pasig City , PH SEA-DO 605-6508900-4/3/1
16AEE45 TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.);METAL;CO
13-NOV-2007 FILTHY
Alliance Tuna International, Inc.
Pasig City , PH SEA-DO 605-6508900-4/4/1
16AEE45 TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.);METAL;CO
13-NOV-2007 FILTHY
Alliance Tuna International, Inc.
Pasig City , PH SEA-DO 605-6508900-4/2/1
16AEE45 TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.);METAL;CO
Partial Refusal 13-NOV-2007 FILTHY
Felicisimo Martinez & Co. Inc.
Quezon City , PH LOS-DO 277-0115445-5/11/1
03FGT99 LA PACITA EGG CRACKLETS BISCUITS
13-NOV-2007 UNSAFE COL
Storck Products Inc
Pasig Rizal, PH LOS-DO 880-0064130-3/7/1
33EGT06 STORCK STAR EUCULYPTUS MENTHOL CANDY
14-NOV-2007 CONTAINER
UNSAFE ADD
POISONOUS
Unilever Philippines Inc
Manila City , PH SAN-DO AWL-0708635-1/22/1A
62SAL01 Creamsilk Itch & Dandruff-Free Conditioner
20-NOV-2007 NOT LISTED
DRUG NAME
Unilever Philippines Inc
Manila City , PH SAN-DO AWL-0708635-1/23/1A
62SAL99 Sunsilk Softening Anti-Dandruff Shampoo
20-NOV-2007 NOT LISTED
DRUG NAME
UNAPPROVED
Splash Corporation
Quezon, Philippines , PH SAN-DO AWL-0708635-1/25/3
63VAL99 LOTION
20-NOV-2007 NOT LISTED
DRUG NAME
UNAPPROVED
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO AWL-0708635-1/25/4A
66PAL99 Block & White Papaya Lotion
20-NOV-2007 NOT LISTED
DRUG NAME
UNAPPROVED
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO AWL-0708635-1/25/4B
66PAL99 Block & White Radiance Lotion
20-NOV-2007 NOT LISTED
DRUG NAME
UNAPPROVED
Unilever Philippines Inc
Manila City , PH SAN-DO AWL-0708635-1/25/5A
63VAL99 Silka Regular Whitening Lotion
20-NOV-2007 NOT LISTED
DRUG NAME
UNAPPROVED
Unilever Philippines Inc
Manila City , PH SAN-DO AWL-0708635-1/25/5B
63VAL99 Silka Papaya Lotion
20-NOV-2007 NOT LISTED
DRUG NAME
UNAPPROVED
Rdl Cosmetics Laboratory Inc
Davao City , PH SAN-DO AWL-0708635-1/27/4
63VAL99 SOAP
20-NOV-2007 NOT LISTED
DRUG NAME
UNAPPROVED
Myeth Medicine
Maren , PH SAN-DO 112-8022367-0/1/1
64GDA16 926738580009 CONJUGATED ESTROGENS
20-NOV-2007 UNAPPROVED
United Laboratories Inc
Mandaluyong Metro Manila , PH 1550 SAN-DO 112-8296348-9/1/1
66VCY99 861601840860 FELDIPINE/HYPERTENSION
20-NOV-2007 UNAPPROVED
Euro Generics International
Makita City , PH SAN-DO 112-8296348-9/1/2
66VCY99 861601840860 ATENOLOL/HYPERTENSION
20-NOV-2007 UNAPPROVED
Euroasia Pharmaceuticals Inc
Quezon City , PH 1147 SAN-DO 112-8296348-9/1/3
66VCY99 861601840860 BEPSTAR/HYPERTENSION
20-NOV-2007 UNAPPROVED
Willore Pharma Corporation
Pasig City , PH SAN-DO 112-8296348-9/1/4
66VCY99 861601840860 DIUZID/HYPERTENSION
20-NOV-2007 UNAPPROVED
Les Aliments Haut Panache
Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/2/1
16CYE45 SPICE TUNA
21-NOV-2007 LIST INGRE
NUTRIT LBL
NEEDS FCE
NO PROCESS
Les Aliments Haut Panache
Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/2/2
16CYE45 TUNA IN WATER
21-NOV-2007 NUTRIT LBL
NEEDS FCE
NO PROCESS
Les Aliments Haut Panache
Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/3/1
16AEE45 TUNA IN OIL
21-NOV-2007 LIST INGRE
NUTRIT LBL
NEEDS FCE
NO PROCESS
Interphil Lab Inc
Laguna , PH SEA-DO 112-0197435-2/1/1
64XCJ07 738115280777 OTC RETIN-A CREAM
23-NOV-2007 UNAPPROVED
Crustacean Trading Corporation
Zamboanga City PH-ZAS, PH 7000 NYK-DO 453-0205788-5/2/1
16MGT09 OCTOPUS WHOLE
27-NOV-2007 SALMONELLA
Marlife Export Corporation
Teguig , PH NYK-DO 551-5352802-6/1/1
16MGT09 WILD CAUGHT OCTOPUS
28-NOV-2007 FILTHY
Angel Seafood Corp.
Santos City , PH SEA-DO 906-0718660-9/4/1
16AGT45 TUNA STEAKS 6 OZ PH 2007
28-NOV-2007 FILTHY
Angel Seafood Corp.
Santos City , PH SEA-DO 906-0718660-9/1/1
16AGT45 TUNA PRIME A
28-NOV-2007 FILTHY
Angel Seafood Corp.
Santos City , PH SEA-DO 906-0718660-9/2/1
16AGT45 TUNA PRIME B
28-NOV-2007 FILTHY
Angel Seafood Corp.
Santos City , PH SEA-DO 906-0718660-9/3/1
16AGT45 TUNA STEAKS 4 OZ PH 2007
28-NOV-2007 FILTHY
Angel Seafood Corp.
Santos City , PH SEA-DO 906-0718660-9/5/1
16AGT45 FROZEN AHI TUNA STKS PH07
28-NOV-2007 FILTHY
SEA GIANT INTERNATIONAL CORPORATON
ZAMBOANGA PH-NOTA, PH 7000 NYK-DO KM6-0034008-7/1/2
16MGD09 FROZEN WHOLE CLEAN OCTOPUS
29-NOV-2007 SALMONELLA
Florence Foods Corp.
Nova , PH NYK-DO TZ6-0066499-7/5/2
04YGT02 QUICKCHOW BIHON
29-NOV-2007 FILTHY
Myra Pharmaceutical Inc
San Juan , PH SEA-DO 112-0093840-8/2/1
62UPA99 861607654089 NEOZEP COLD TABLETS
29-NOV-2007 UNAPPROVED
D'World 2000 Enterprises Corporation
Quezon PH-NOTA, PH 1104 SAN-DO D11-0111868-9/8/1
38CGT99 TAMARIND SOUP MIX
30-NOV-2007 FILTHY