Refusal Actions by FDA as Recorded in OASIS for Canada
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Advanced Orthomolecular Research
Calgary Ca-Ab, CA T2E 6X8 SEA-DO 310-1301455-6/1/1
60LAE99 ALLGESIC - DIETARY SUPPLEMENT
02-JAN-2008 UNAPPROVED
Master Delight Inc
Mississauga ON, CA L5S1V4 DET-DO 551-7030626-5/1/1
33EGT99 Malban Bulk with Pistachios
03-JAN-2008 UNSAFE COL
COLOR LBLG
Master Delight Inc
Mississauga ON, CA L5S1V4 DET-DO 551-7030626-5/1/2
33EGT99 Malban Plate Turkish Delight with Pistachios
03-JAN-2008 UNSAFE COL
COLOR LBLG
Master Delight Inc
Mississauga ON, CA L5S1V4 DET-DO 551-7030626-5/1/4
33EGT99 Malban Bulk with Apricot & Pistachios
03-JAN-2008 UNSAFE COL
COLOR LBLG
Eau Zone Oils & Fragrances Ltd
Montreal QC, CA H4N2S7 NYK-DO 110-7573286-9/15/1
60QBJ56 Sensations Balm "Blazing Cherry"
03-JAN-2008 COL ADDED
N-RX INACT
INCONSPICU
Janssen Pharmaceutical
North York ON, CA M3C1L9 DET-DO 112-0248059-9/1/1
60SCH21 907031570362 CISAPRIDE (PROPULSID)
03-JAN-2008 DIRECTIONS
PERSONALRX
UNAPPROVED
Pyng Medical Corporation
Richmond BC, CA V6V2E9 SEA-DO 110-1246965-2/1/1
80F--MI HYPODERMIC NEEDLES
03-JAN-2008 REGISTERED
Alpha Health Products
Burnaby BC, CA V5J5B9 SEA-DO 110-1402925-6/1/1
54FEC99 KEFIR GRANULES
03-JAN-2008 LIST INGRE
LACKS FIRM
LABELING
NUTRIT LBL
HEALTH C
Master Delight Inc
Mississauga ON, CA L5S1V4 DET-DO 112-8662100-0/1/1
33GGT99 Malban Bulk with Pistachios
04-JAN-2008 UNSAFE COL
LIST INGRE
Master Delight Inc
Mississauga ON, CA L5S1V4 DET-DO 112-8662100-0/1/4
33KGT99 Malban Bulk with Apricot and Pistachios
04-JAN-2008 UNSAFE COL
LIST INGRE
Master Delight Inc
Mississauga ON, CA L5S1V4 DET-DO 112-8662100-0/1/2
33GGT99 Malban Plate Turkish Delight with Pistachio
04-JAN-2008 UNSAFE COL
LIST INGRE
Be Well Homeopathics
Miami, FL 33172-4800 SEA-DO 110-1355969-1/1/1
66VAL99 BeWell Flu Terminator Drops - Homeopathic Medicine
04-JAN-2008 NOT LISTED
Pharmascience Inc.
Montreal QC, CA H4P2T4 SAN-DO 112-0572269-0/1/1
56YCC99 858927113376 DOMPERIDONE
04-JAN-2008 UNAPPROVED
Medvet Pharmaceuticals
High Riverhigh River ALBERTA, CA T1V1E6 CIN-DO 110-1396949-4/1/1
56LYR12 FUMAGILIN/FOR VET USE ONLY
08-JAN-2008 NOT LISTED
DIRECTIONS
RITCHIE FEED & SEED INC.
Nepean CA-ON, CA K2G3R8 NYK-DO 551-7220548-1/1/1
70MY-01 22% DAIRY PELLETS
08-JAN-2008 LIST INGRE
RITCHIE FEED & SEED INC.
Nepean CA-ON, CA K2G3R8 NYK-DO 551-7220548-1/1/3
70MY-01 16% DAIRY PELLETS
08-JAN-2008 LIST INGRE
RITCHIE FEED & SEED INC.
Nepean CA-ON, CA K2G3R8 NYK-DO 551-7220548-1/1/4
70MY-01 18% DAIRY PELLETS
08-JAN-2008 LIST INGRE
Feature Foods Limited
Etobicoke ON, CA M9W1A3 DET-DO 112-8778261-1/1/1A
27YCI04 Horseradish
10-JAN-2008 INSANITARY
NUTRIT LBL
Feature Foods Limited
Etobicoke ON, CA M9W1A3 DET-DO 112-8778261-1/1/1B
27YCI04 Horseradish with Beets
10-JAN-2008 PRESRV LBL
INSANITARY
NUTRIT LBL
4ever Fit
Kelowna BC, CA V1X7Y5 NOL-DO 112-0813919-9/1/1
54ABA90 799773750220 L-Arginine (SUPPLEMENTS)
10-JAN-2008 DIETARYLBL
NUTRIT LBL
Siddiqui Ali
Mississauga ON, CA L5R3Z5 NOL-DO 112-0839719-3/1/1
54FYY99 863545601421 SUGAR PILLS HOMEOPATHIC
10-JAN-2008 LIST INGRE
DIETARYLBL
LABELING
NUTRIT LBL
Vita Health Company Lts
Winnipeg MB, CA R2J3W2 SAN-DO 112-0617360-4/1/1
60LPB05 792468733627 OTC ASPIRIN
10-JAN-2008 NOT LISTED
Merck Frosst Canada, Ltd.
Kirkland QC, CA H9H3L1 NOL-DO 112-0934606-6/1/1
64UCB06 863547857444.PROSCAR 5MG
11-JAN-2008 UNAPPROVED
Oakrun Farm Bakery Limited
Ancaster ON, CA L9G3L3 DET-DO 112-0928761-7/1/1
03REN35 Supreme Raspberry Danish Ring
14-JAN-2008 UNSAFE COL
COLOR LBLG
Korex Canada Limited
Etobicoke ON, CA M8Z2J8 NYK-DO WFN-8049506-8/1/1
53BH-01 ALPEN BATH SALT
14-JAN-2008 CSTIC LBLG
Canada China Air Express Inc
Richmond BC, CA V6X2A4 SEA-DO 110-1499271-9/1/1
89L--YG TENDER SKIN MACHINE
16-JAN-2008 NOT LISTED
REGISTERED
Matol Botanical International
Lachine QC, CA H8T3C5 NYK-DO 300-2361687-1/6/1
03SAB01 CAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING;FABRI
17-JAN-2008 CYCLAMATE
Matol Botanical International
Lachine QC, CA H8T3C5 NYK-DO 300-2361687-1/10/1
03SFB23 PANCAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING;PA
17-JAN-2008 CYCLAMATE
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 802-0022202-6/1/1
65JDY29 LO-ORVAL TABLETS (END USER: WYETH)
18-JAN-2008 UNAPPROVED
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 802-0022202-6/2/1
64NCA04 FERROUS FUMARATE (LOTS 464780 + 473285)
18-JAN-2008 UNAPPROVED
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 802-0021316-5/1/1
65JDY29 LO-OVRAL TABLETS (END USER:WYETH) NOT FOR HUMAN USE
18-JAN-2008 UNAPPROVED
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 802-0021512-9/1/1
65JDY29 LO-OVRAL TABLETS(END USER:WYETH) NOT FOR HUMAN USE
18-JAN-2008 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0021725-7/1/1
65JDY29 LO-ORVAL TABLETS (END USER:WYETH) IMPORTED FOR PACKAGING
18-JAN-2008 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0021819-8/2/1
65JDY29 LO-ORVAL TABLETS(END USER:WYETH)
18-JAN-2008 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0021819-8/1/1
64NCA04 FERROUS FUMARATE TABLETS(END USER:WYETH)
18-JAN-2008 UNAPPROVED
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 802-0022026-9/1/1
65JDY29 LO-ORVAL TABLETS(END USER:WYETH) NOT FOR HUMAN USE
18-JAN-2008 UNAPPROVED
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 802-0022026-9/2/1
64NCA04 FERROUS FUMARATE (END USER:WYETH)
18-JAN-2008 UNAPPROVED
Saffar Bulgur
North York ON, CA M3J2N1 DET-DO G17-0008069-1/2/1
23MHT01 Tahina
22-JAN-2008 SALMONELLA
Global Botannical Corp Ltd
Barrie ON, CA L4N8Z6 NYK-DO 110-1319136-2/1/1
54YCR99 FEBERRIFIC
24-JAN-2008 DIETARYLBL
NUTRIT LBL
Melo's Food Centre Ltd.
Toronto CA-ON, CA M5T2L4 NYK-DO 112-0696532-2/2/1
23KGT01 TOASTED PUMPKIN SEEDS
24-JAN-2008 UNSAFE COL
LABELING
Laboratoire Manuves
Pointe-claire QC, CA H9R3S3 NYK-DO 110-1308257-9/1/1
61PBL99 Diabetin (Ampoules)
24-JAN-2008 UNAPPROVED
Vimex Pharma Inc
Ilderton ON, CA N0M2A0 NYK-DO 110-1407071-4/1/1
63VBJ99 HIRUVAL 35 CREAM
24-JAN-2008 NOT LISTED
Cambie Pharmascue #37
Vancouver BC, CA V5Z2X8 SEA-DO 110-1633923-2/1/1
66VDY99 DIOOCEN
24-JAN-2008 UNAPPROVED
Cambie Pharmascue #37
Vancouver BC, CA V5Z2X8 SEA-DO 110-1633923-2/1/2
66VDY99 ZOLAFT
24-JAN-2008 UNAPPROVED
Cambie Pharmascue #37
Vancouver BC, CA V5Z2X8 SEA-DO 110-1633923-2/1/3
66VDY99 CERDIZENN
24-JAN-2008 UNAPPROVED
Ratiopharm Inc
Mirabel QC, CA J7J1P3 DET-DO 112-1158381-3/1/1
64LCL08 863547857065 Betamethasone Valerate Lotion
24-JAN-2008 DIRECTIONS
UNAPPROVED
Marine Harvest Canada
Campbell River BC, CA V9W2Z3 SEA-DO MK8-0355178-9/2/1
16XGT03 FARMED ATLANTIC SALMON, FILLET FRESH
25-JAN-2008 FILTHY
Homeocan Inc
Lasalle QC, CA H8N2H2 SAN-DO 112-0814866-1/2/1
62GAB99 862565875880 HOMEPATHIC DROPS
25-JAN-2008 NOT LISTED
Patheon Inc. - Whitby Operations
Whitby Ontario, CA L1N 5Z5 NYK-DO M76-8705228-3/1/1
66VIS99 CONTRAVE BULK TABLETS (4MG/90MG)
28-JAN-2008 UNAPPROVED
Biotech Inc
Markham ON, CA L3R4G7 NYK-DO 110-8309795-8/1/1
78M--SY URINALYSIS REAGENT STRIPS
28-JAN-2008 NOT LISTED
NO 510(K)
Medicam Inc
Montreal QC, CA H3W1Y3 NOL-DO 112-8058405-5/2/1
80L--DQ 857394167109/ATOMIZER BEAUTY ESTHETIC EQ
28-JAN-2008 NOT LISTED
LACKS FIRM
Pfizer Canada Inc
Pointe Claire, Quebec, CA H9R 4V2 NOL-DO 112-8078911-8/1/1
61WCB45 861877668102.DIFLUCAN 5MG
28-JAN-2008 UNAPPROVED
Promising Health Inc
Markham ON, CA L3R0J1 NOL-DO 112-8118115-8/1/1
54ACY99 850244551245 Activa Total Protection (Antioxidant for the Sk
28-JAN-2008 LIST INGRE
NO ENGLISH
Campbell Soup
Etobicoke ON, CA M8V2B8 NYK-DO 112-0950707-1/1/1
38ADE27 GARDENNAY HERBED TOMATO
29-JAN-2008 NO PROCESS
Campbell Soup
Etobicoke ON, CA M8V2B8 NYK-DO 112-0950707-1/2/1
38ADE28 GARDENNAY BLOND CTY VEGETABLE
29-JAN-2008 NO PROCESS
Campbell Soup
Etobicoke ON, CA M8V2B8 NYK-DO 112-0950707-1/6/1
38FDE05 GARDENNAY BROCCOLI REAL PARMESEAN
29-JAN-2008 NO PROCESS
Campbell Soup
Etobicoke ON, CA M8V2B8 NYK-DO 112-0950707-1/7/1
38ADF07 GARDENNAY SANTE FE SWEET CORN W/ CHIPOLT
29-JAN-2008 NO PROCESS
Campbell Soup
Etobicoke ON, CA M8V2B8 NYK-DO 112-0950707-1/8/1
38ADE23 GARDENNAY FIELD POTATO W/ SPRING LEAK
29-JAN-2008 NO PROCESS
Gourmet Du Village Morin Heights
Morin-Heights QC, CA J0R1H0 NYK-DO 110-7542508-4/2/1
33EDT99 Deck The Halls (Chocolate Mix & Candy Cane)
29-JAN-2008 UNSAFE COL
LIST INGRE
Confiserie Regal Confections
Laval Quebec, CA H7L5A3 MIN-DO 110-1238908-2/1/1B
33SYT99 Blue Whales (Candy)
29-JAN-2008 UNSAFE COL
Confiserie Regal Confections
Laval Quebec, CA H7L5A3 MIN-DO 110-1238908-2/1/1A
33SYT99 LICORICE BABIES
29-JAN-2008 UNSAFE COL
Bill Beauty & Health Product Ltd.
Scarborough CA-ON, CA M1B2X6 NYK-DO D03-0159391-5/1/1
54YCH99 Osteo Complex (475 mg capsules)
29-JAN-2008 DIETARYLBL
Bill Beauty & Health Product Ltd.
Scarborough CA-ON, CA M1B2X6 NYK-DO D03-0159391-5/2/1
54YCH99 Suglex Diabetic Support - Hard gels
29-JAN-2008 DIETARYLBL
Bill Beauty & Health Product Ltd.
Scarborough CA-ON, CA M1B2X6 NYK-DO D03-0159391-5/3/1
54YCH99 Natural Lecithin (1200 mg Soft Gels)
29-JAN-2008 DIETARYLBL
Terravita
Brampton ON, CA L6R1W4 NYK-DO BLP-0024280-5/1/1
54YCT99 BOLDO LEAF (BAGGED)
30-JAN-2008 HEALTH C
Terravita
Brampton ON, CA L6R1W4 NYK-DO BLP-0024280-5/2/1
54YCT99 BLADDERWRACK KELP (BAGGED) (LOOSE)
30-JAN-2008 HEALTH C
Terravita
Brampton ON, CA L6R1W4 NYK-DO BLP-0024280-5/3/1
54YCT99 VERVAIN (VERBENA) BLUE (BAGGED)
30-JAN-2008 HEALTH C
Phytovie
Ste-Julie QUEBEC, CA J3E1Z2 NYK-DO BLP-0024280-5/8/1
54YCW99 BLACK CURRANT CASSIS (BAGGED)
30-JAN-2008 HEALTH C
Terravita
Brampton ON, CA L6R1W4 NYK-DO BLP-0024280-5/9/1
54YCT99 GINKGO BILOBA (BAGGED)
30-JAN-2008 NUTRIT LBL
Terravita
Brampton ON, CA L6R1W4 NYK-DO BLP-0024280-5/10/1
54YCC99 JAVA (BAGGED) (ORTHOSIPHON) 450 MG
30-JAN-2008 HEALTH C
Playtex
Mississauga ON, CA L4V1H8 NWE-DO 300-2337605-4/6/1
66PBL99 SUNCARE
30-JAN-2008 NOT LISTED
UNAPPROVED
Playtex
Mississauga ON, CA L4V1H8 NWE-DO 300-2337605-4/7/1
66PBL99 SUNCARE
30-JAN-2008 NOT LISTED
UNAPPROVED
Playtex
Mississauga ON, CA L4V1H8 NWE-DO 300-2337605-4/8/1
66PBL99 SUNCARE
30-JAN-2008 NOT LISTED
UNAPPROVED
Playtex
Mississauga ON, CA L4V1H8 NWE-DO 300-2337605-4/9/1
66PBL99 SUNCARE
30-JAN-2008 NOT LISTED
UNAPPROVED
Signature Bakery Inc
North York ON, CA M3J2J2 NYK-DO 112-0955592-2/1/1
03RYY01 859198408269 APPLE COFFEE CAKE
30-JAN-2008 UNSAFE COL
R. Misir
Scarborough ON, CA M1L4C3 DET-DO 110-1490611-5/1/1
61JBY16 CHOLESTEROL MEDICATION
31-JAN-2008 DIRECTIONS
PERSONALRX
UNAPPROVED