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
Skin Sciences Laboratory, Inc.
Pasig City , PH 1611 SAN-DO 112-2024052-0/1/1
66VBY99 861607615633 SUNSCREEN FACE COVER 45
05-MAY-2008 NOT LISTED
UNAPPROVED
SEACHAMP INTERNATIONAL EXPORT CORP.
PASAY CITY Ph-Nota, PH 1300 LOS-DO 221-1885681-8/1/1
16WGT01 STUFFED MILKFISH
06-MAY-2008 SALMONELLA
Angel Seafoods Corporation
General Santos City PH-SAR, PH 9500 LOS-DO 221-1880905-6/1/1
16AGT45 FROZEN TUNA PROCESSED WITH CARBON MONOXIDE/ YELLOWFIN TUNA S
13-MAY-2008 FILTHY
Angel Seafoods Corporation
General Santos City PH-SAR, PH 9500 LOS-DO 221-1880905-6/1/2
16AGT45 FROZEN TUNA PROCESSED WITH CARBON MONOXIDE/ YELLOWFIN TUNA W
13-MAY-2008 FILTHY
Angel Seafoods Corporation
General Santos City PH-SAR, PH 9500 LOS-DO 221-1880905-6/1/3
16AGT45 FROZEN TUNA PROCESSED WITH CARBON MONOXIDE/ YELLOWFIN TUNA S
13-MAY-2008 FILTHY
Angel Seafoods Corporation
General Santos City PH-SAR, PH 9500 LOS-DO 221-1880905-6/1/4
16AGT45 FROZEN TUNA PROCESSED WITH CARBON MONOXIDE/ YELLOWFIN TUNA W
13-MAY-2008 FILTHY
Angel Seafoods Corporation
General Santos City PH-SAR, PH 9500 LOS-DO 221-1880905-6/1/7
16AGT45 FROZEN TUNA PROCESSED WITH CARBON MONOXIDE/ BIG EYE TUNA SAK
13-MAY-2008 FILTHY
Angel Seafoods Corporation
General Santos City PH-SAR, PH 9500 LOS-DO 221-1880905-6/1/8
16AGT45 FROZEN TUNA PROCESSED WITH CARBON MONOXIDE WIDE SAKU BLOCK
13-MAY-2008 FILTHY
Angel Seafoods Corporation
General Santos City PH-SAR, PH 9500 LOS-DO 221-1880905-6/1/10
16AGT45 FROZEN TUNA PROCESSED WITH CARBON MONOXIDE/ BIG EYE TUNA WID
13-MAY-2008 FILTHY
Unilever Philippines Inc
Manila City , PH LOS-DO 551-6659066-6/2/1
16YCE99 TUNA SPREAD
13-MAY-2008 NEEDS FCE
NO PROCESS
Solvang Pharma Inc
Quezon City , PH SAN-DO 112-2172237-7/1/4
63XDY99 864540834813 CISTRON
14-MAY-2008 NOT LISTED
UNAPPROVED
Procter And Gamble
Quezon City , PH SAN-DO 112-2172237-7/1/1
63XDY99 864540834813 INHALER
14-MAY-2008 NOT LISTED
UNAPPROVED
Pharmasia-Cuvest Inc
Makati City , PH SAN-DO 112-2172237-7/1/2
66FAA99 864540834813 METHYRED
14-MAY-2008 NOT LISTED
UNAPPROVED
Zuellig Pharma Corporation
Makati , PH 1200 SAN-DO 112-2172237-7/1/3
61EBA99 864540834813 ANSIMAR
14-MAY-2008 NOT LISTED
UNAPPROVED
Zuellig Pharma Corporation
Makati , PH 1200 SAN-DO 112-2172237-7/1/5
62OBA41 864540834813 LOSARTAN
14-MAY-2008 NOT LISTED
UNAPPROVED
Reysons EXIM International Inc.
Quezon PH-QUE, PH 1103 CHI-DO BSL-0403094-7/15/1
25LCE12 PURPLE YAM JAM;GLASS BOTTLE;PKGD.
19-MAY-2008 NEEDS FCE
NO PROCESS
Farmland Processing And Manufacturing Corp
Makati City , PH SEA-DO EH5-0041440-2/9/1
16AET45 CENTURY TUNA - ORIGINAL
20-MAY-2008 NEEDS FCE
NO PROCESS
Farmland Processing And Manufacturing Corp
Makati City , PH SEA-DO EH5-0041440-2/10/1
16AET45 CENTURY TUNA - HOT AND SPICY
20-MAY-2008 NEEDS FCE
NO PROCESS
Farmland Processing And Manufacturing Corp
Makati City , PH SEA-DO EH5-0041440-2/11/1
16AET45 CENTURY TUNA - ADOBO
20-MAY-2008 NEEDS FCE
NO PROCESS
Farmland Processing And Manufacturing Corp
Makati City , PH SEA-DO EH5-0041440-2/12/1
16AET45 CENTURY TUNA - MECHADO
20-MAY-2008 NEEDS FCE
NO PROCESS
Therapharma
Metro Manila , PH SAN-DO 112-2389939-7/1/1
62OCA14 864541344920 AMLODPINE CAMSYLATE
21-MAY-2008 NOT LISTED
UNAPPROVED
Therapharma
Metro Manila , PH SAN-DO 112-2389939-7/1/2
62OCA41 864541344920 LOSARTAN POTASSIUM
21-MAY-2008 NOT LISTED
UNAPPROVED
Schwarz
Makati City , PH SAN-DO 112-2389939-7/1/3
66SCA24 864541344920 ISOSORBIDE DINITRATE
21-MAY-2008 NOT LISTED
UNAPPROVED
Pharex
Quezen City , PH SAN-DO 112-2389939-7/1/4
61JCA14 864541344920 SIMVASTATIN
21-MAY-2008 NOT LISTED
UNAPPROVED
Therapharma
Metro Manila , PH SAN-DO 112-2389939-7/2/1
61PCA31 864541344920 GLIMEPIRIDE NORIZEC
21-MAY-2008 NOT LISTED
UNAPPROVED
Pharex
Quezen City , PH SAN-DO 112-2389939-7/2/2
60XCA02 864541344920 NEOBLOC (METOPROLOL)
21-MAY-2008 NOT LISTED
UNAPPROVED
Aventis
Makati City , PH SAN-DO 112-2389939-7/2/3
64BCA24 864541344920 FUROSEMIDE (LASIX)
21-MAY-2008 NOT LISTED
UNAPPROVED
Philippine-Oahu Marketing, Inc
Calamba PH-LAG, PH 4027 SAN-DO J14-0060048-9/53/1
21UGT14 TAMARIND CANDY
21-MAY-2008 FILTHY
TRIDEM PROCESSING & MARKETING CORPORATION
MAKATI PH-RIZ, PH 1200 SEA-DO EH5-0041364-4/2/1
23ECT05 MACAPUNO STRINGS
22-MAY-2008 NEEDS FCE
NO PROCESS
TRIDEM PROCESSING & MARKETING CORPORATION
MAKATI PH-RIZ, PH 1200 SEA-DO EH5-0041364-4/22/1
16AEE33 SABA SARDINES RED
22-MAY-2008 LIST INGRE
NEEDS FCE
NO PROCESS
Aling Conching Native Products
Pamapnga , PH SEA-DO EH5-0041364-4/42/1
33EGT99 SALTED TAMARIND CANDY
22-MAY-2008 FILTHY
Aling Conching Native Products
Pamapnga , PH SEA-DO EH5-0041364-4/43/1
33EGT99 SWEET TAMARIND CANDY
22-MAY-2008 FILTHY
Rdl Pharmaceutical
Diauao City , PH DET-DO 112-2841882-1/1/1
63VBY02 963086705576 HYDROQUINONE TRETINOIN
23-MAY-2008 DIRECTIONS
PERSONALRX
UNAPPROVED
Splash Corporation
Valenzuela City , PH SAN-DO EBH-0061093-4/64/1
66VDJ99 Maxi-Peel Exfoliant
28-MAY-2008 NOT LISTED
FALSE
UNAPPROVED
Frescomar Seahelm Corp.
General Santos City PH-SAR, PH 9500 NYK-DO H67-1311231-5/4/1
16AFD45 FROZEN TUNA STEAK
29-MAY-2008 FILTHY