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
Lise Watier Cosmetiques Inc
Montreal QC, CA H4T1B4 NOL-DO 112-0725820-6/1/1
65LBJ99 864077017672/TEINT LIFT ANTI-RIDES FPS 20 SPF Anti-Wrinkle F
02-JUN-2008 NOT LISTED
Lise Watier Cosmetiques Inc
Montreal QC, CA H4T1B4 NOL-DO 112-0725820-6/1/2
65LBL99 864077017672/SYSTEME ANTI-RIDES BIO PRO SPF 15 Day Fluid & S
02-JUN-2008 NOT LISTED
Vita Health Company Lts
Winnipeg MB, CA R2J3W2 SAN-DO 112-2625524-1/1/1
65QBB99 859019771703 LAXITIVE VITAMIN
02-JUN-2008 NOT LISTED
Gfr Pharma Ltd
Maple Ridge BC, CA V2X0Y4 NYK-DO UPS-0908063-5/91/1
54FCA03 US VIGOR - WOMEN'S (60 TABLETS/BOTT MAIN INGREDIENT-DONG QUA
03-JUN-2008 LIST INGRE
X4 Labs Inc.
Montreal QC, CA H3N2C7 NYK-DO XXX-0154399-1/1/1
78N--HU MECHANICAL PENILE EXTENDER
03-JUN-2008 DIRECTIONS
Apollo Health And Beauty Care
Concord ON, CA L4K5M8 NYK-DO 336-5127391-7/3/1
85N--UC RITE AID WARMING LUBRICANT
05-JUN-2008 NO 510(K)
Sun Force International Products
Aldergrove British Columbia, CA V4W3Z4 SEA-DO UPS-1217953-5/1/1
66VBL99 RESPIRACTIN HERBAL TONIC PN080080669281
05-JUN-2008 UNAPPROVED
Sun Force International Products
Aldergrove British Columbia, CA V4W3Z4 SEA-DO UPS-1233364-5/1/1
66VBL99 RESPIRACTIN HERBAL
05-JUN-2008 UNAPPROVED
Sun Force International Products
Aldergrove British Columbia, CA V4W3Z4 SEA-DO UPS-1233374-4/1/1
66VBL99 RESPIRACTIN HERBAL
05-JUN-2008 UNAPPROVED
Sun Force International Products
Aldergrove British Columbia, CA V4W3Z4 SEA-DO UPS-1233394-2/1/1
66VBL99 RESPIRACTIN HERBAL
05-JUN-2008 UNAPPROVED
Sun Force International Products
Aldergrove British Columbia, CA V4W3Z4 SEA-DO UPS-1233403-1/1/1
66VBL99 RESPIRACTIN
05-JUN-2008 UNAPPROVED
Sun Force International Products
Aldergrove British Columbia, CA V4W3Z4 SEA-DO UPS-1248740-9/1/1A
66VBL99 RESPIRACTIN HERBAL TONIC
05-JUN-2008 UNAPPROVED
Sun Force International Products
Aldergrove British Columbia, CA V4W3Z4 SEA-DO UPS-1248740-9/1/1B
66VBL99 RESPIRACTIN HERBAL TONIC
05-JUN-2008 UNAPPROVED
Sun Force International Products
Aldergrove British Columbia, CA V4W3Z4 SEA-DO UPS-1248740-9/1/1C
66VBL99 Childrens RESPIRACTIN HERBAL TONIC
05-JUN-2008 UNAPPROVED
Sun Force International Products
Aldergrove British Columbia, CA V4W3Z4 SEA-DO UPS-1248845-6/1/1
66VBL99 RESPIRACTIN HERBAL TONIC PN080080804646
05-JUN-2008 UNAPPROVED
Impair Aware Inc
Donnacona QUEBEC, CA G3M1K5 NYK-DO 310-1311519-7/1/1
91D--JD BREATH ALCOHOL TESTER
06-JUN-2008 NOT LISTED
NO 510(K)
RITCHIE FEED & SEED INC.
Nepean CA-ON, CA K2G3R8 NYK-DO 551-6026056-3/1/1
70MY-01 18% DAIRY PELLETS
06-JUN-2008 LIST INGRE
RITCHIE FEED & SEED INC.
Nepean CA-ON, CA K2G3R8 NYK-DO 551-6026056-3/2/1
70MY-01 24% DAIRY PELLETS
06-JUN-2008 LIST INGRE
RITCHIE FEED & SEED INC.
Nepean CA-ON, CA K2G3R8 NYK-DO 551-6026056-3/3/1
70MY-01 16% DAIRY PELLETS
06-JUN-2008 LIST INGRE
Sun Force International Products
Aldergrove British Columbia, CA V4W3Z4 SEA-DO UPS-1308000-5/1/1
66VBL99 RESPIRACTIN HERBAL TONIC PN080081059483
06-JUN-2008 UNAPPROVED
Twi Foods Inc
Mississauga ON, CA L6T1S3 DET-DO BGK-0025364-2/11/1
03MHT99 Butterfly Cookies
09-JUN-2008 NUTRIT LBL
Twi Foods Inc
Mississauga ON, CA L6T1S3 DET-DO BGK-0025364-2/12/1
03RGT03 Fruit Cake
09-JUN-2008 NUTRIT LBL
Pharmacie Frayne
Montreal QC, CA H3S1Z1 NOL-DO 112-2980317-9/1/1
66VIP99 850619887483 PLACEBO
09-JUN-2008 UNAPPROVED
Pharmacie Frayne
Montreal QC, CA H3S1Z1 NOL-DO 112-2980317-9/1/2
61NBY05 850619887483 BUPROPION
09-JUN-2008 UNAPPROVED
Pharmacie Frayne
Montreal QC, CA H3S1Z1 NOL-DO 112-2980443-3/1/1
66VIP99 849191746295 PLACEBO STUDY DRUG
09-JUN-2008 UNAPPROVED
Pharmacie Frayne
Montreal QC, CA H3S1Z1 NOL-DO 112-2980443-3/2/1
61NIY05 849191746295 BUPROPION STUDY DRUG
09-JUN-2008 UNAPPROVED
Pharmacie Frayne
Montreal QC, CA H3S1Z1 NOL-DO 112-2980497-9/1/1
66VIP99 849191746300 PLACEBO STUDY DRUG TABLETS
10-JUN-2008 UNAPPROVED
Pharmacie Frayne
Montreal QC, CA H3S1Z1 NOL-DO 112-2980497-9/2/1
61NIY05 849191746300 BUPROPION STUDY DRUG
10-JUN-2008 UNAPPROVED
Pharmacie Frayne
Montreal QC, CA H3S1Z1 NOL-DO 112-2980395-5/1/1
66VIP99 849191746284 PLACEBO STUDY TABLETS
10-JUN-2008 UNAPPROVED
Pharmacie Frayne
Montreal QC, CA H3S1Z1 NOL-DO 112-2980395-5/2/1
61NIY05 849191746284 BUPROPION STUDY DRUG
10-JUN-2008 UNAPPROVED
Pharmacie Frayne
Montreal QC, CA H3S1Z1 NOL-DO 112-2980595-0/1/1
66VIP99 850619887472 PLACEBO STUDY DRUG TABLETS
10-JUN-2008 UNAPPROVED
Pharmacie Frayne
Montreal QC, CA H3S1Z1 NOL-DO 112-2980595-0/2/1
61NIY05 850619887472 BUPROPION STUDY TABLETS
10-JUN-2008 UNAPPROVED
Itn Food Corporation
Scarborough ON, CA M1S3S2 DET-DO BGK-0025351-9/19/1
37JCI99 Samosa Dipping Sauce
10-JUN-2008 PRESRV LBL
USUAL NAME
NUTRIT LBL
NO PROCESS
Itn Food Corporation
Scarborough ON, CA M1S3S2 DET-DO BGK-0025351-9/20/1
28LCI02 Garlic Dipping Sauce
10-JUN-2008 INSANITARY
USUAL NAME
NUTRIT LBL
NO PROCESS
Itn Food Corporation
Scarborough ON, CA M1S3S2 DET-DO BGK-0025351-9/21/1
28CCI43 Sesame Dipping Sauce
10-JUN-2008 INSANITARY
NUTRIT LBL
NO PROCESS
Itn Food Corporation
Scarborough ON, CA M1S3S2 DET-DO BGK-0025351-9/22/1A
28KGT99 TANDOORI SPICE MIX (IN PLASTIC JARS)
10-JUN-2008 UNSAFE COL
USUAL NAME
TRANSFAT
Itn Food Corporation
Scarborough ON, CA M1S3S2 DET-DO BGK-0025351-9/22/1B
37JCI99 Coriander Cilantro Dipping Sauce
10-JUN-2008 INSANITARY
NUTRIT LBL
NO PROCESS
Itn Food Corporation
Scarborough ON, CA M1S3S2 DET-DO BGK-0025351-9/43/1
28KGT99 Tandoori Paste
10-JUN-2008 UNSAFE COL
USUAL NAME
TRANSFAT
Apollo Health And Beauty Care
Concord ON, CA L4K5M8 NYK-DO 336-5126328-0/3/1
80K--MJ Warming Lubricant
10-JUN-2008 NO 510(K)
Apollo Health And Beauty Care
Concord ON, CA L4K5M8 NYK-DO 336-5128554-9/4/1
80K--MJ Warming Lubricant
10-JUN-2008 NO 510(K)
Maui Jim
Mississauga ON, CA L5N2M2 NOL-DO 112-2812856-0/1/1
86H--QZ 864285744944 Optical Frames
11-JUN-2008 NOT LISTED
IND Diagnostic Inc.
Delta BC, CA V3M6S7 CIN-DO AEK-9480290-3/1/1
88L--DT DIAGNOSTIC TEST KITS
12-JUN-2008 NOT LISTED
INCONSPICU
NO 510(K)
Rhema Industries Ltd
Coquitlam BC, CA V3K7B4 SEA-DO 144-1628989-3/1/1
54HCH04 Marine Omega Supplement with Fish Oil and Neptune Krill Oil
12-JUN-2008 LIST INGRE
PESTICIDES
Pauls Point Fisheries
Hackett's Cove CA-NS, CA B3Z 3K7 SEA-DO MK8-0379819-0/1/1
16AGD99 FROZEN SKIN OFF HAGFISH
12-JUN-2008 FILTHY
Westmoreland Sales
Leamington ON, CA N8H4W4 DET-DO F57-2806712-8/3/1
24FGC20 Hydroponically Grown Seedless Cucumbers (XL)
13-JUN-2008 PESTICIDE
Albion Fisheries Ltd.
Vancouver BC, CA V5T1E1 SEA-DO MK8-0383949-9/3/1
16XGC32 OYSTERS FRESH FARMED
16-JUN-2008 FALSE
Taro Pharmaceuticals, Inc.
Brampton ON, CA L6T1C1 CIN-DO UPS-1173840-6/1/1
61WCJ04 CLOTRIMAZOLE CREAM, NO RX, NO FOR ID, PER USE
18-JUN-2008 UNAPPROVED
Ratiopharm Inc.
Mirabel QC, CA J7J1P3 CIN-DO UPS-1173840-6/1/2
64LDJ08 RATIO-ECTOSONE CREAM, NO RX, NO FOR ID, PER USE
18-JUN-2008 UNAPPROVED
1329729 Ontario Inc DBA Westmoreland Sales
Leamington Ontario, CA N8H3V5 NYK-DO F57-3679136-2/4/1
24FGC20 Baby Seedless Cucumbers
18-JUN-2008 PESTICIDE
Caribbean Ice Cream Co Ltd
North York ON, CA M4A1X5 DET-DO F57-3674895-8/2/1
29ACO07 CRANBERRY JUICE
18-JUN-2008 INCONSPICU
Caribbean Ice Cream Co Ltd
North York ON, CA M4A1X5 DET-DO F57-3674895-8/3/1
29ACO07 PAPAYA
18-JUN-2008 INCONSPICU
Comcare Health
Burlington ON, CA L7N3G7 NOL-DO 112-2801028-9/1/1
75J--QC 862821586591 CENTRIFUGE
18-JUN-2008 NOT LISTED
REGISTERED
A Couple Of Squares
London ON, CA N5W3R1 DET-DO UPS-1427952-3/1/1
03HFY99 SUGAR COOKIES PN080081526593
19-JUN-2008 UNSAFE COL
COLOR LBLG
Pvl Nutrients Ltd
Port Coquitlam BC, CA V3C6N9 SEA-DO 112-2799789-0/1/1
54FCR12 JUMP-START GINSENG & GINKO BILOBA DIETARY SUPPLEMENT
19-JUN-2008 SBGINSENG
Wyeth Consumer Hea
Mississauga ON, CA L4Z3M6 NOL-DO 112-3117977-4/1/1
60LDA05 928169657616/ ROBAXICET 400 MG
19-JUN-2008 UNAPPROVED
Innova Corporation
Toronto ON, CA M5G1W7 NOL-DO 112-3154820-0/1/1
76N--DP 942525015961-IMPLANTS DENTAL
19-JUN-2008 NOT LISTED
Confiserie Banana
Brebeuf CA-QC, CA J0T1B0 NYK-DO UPS-1158579-9/1/1
33SGT01 EDIBLE MINI MARZIPAN
19-JUN-2008 LIST INGRE
LACKS FIRM
LACKS N/C
USUAL NAME
NUTRIT LBL
Confiserie Banana
Brebeuf CA-QC, CA J0T1B0 NYK-DO UPS-1158579-9/2/1
33SGT01 EDIBLE MARZIPAN FIGURES
19-JUN-2008 LIST INGRE
LACKS FIRM
LACKS N/C
USUAL NAME
NUTRIT LBL
Prime Pacific Intern. Quality Products World Wide Ltd.
North Vancouver BC, CA V7H1T6 CIN-DO UPS-1273764-7/1/1
78K--PL COLON HYDROTHERAPY EQUIPMENT & SUP/FOR INDIVIDUAL, ESTEBAN C
20-JUN-2008 DIRECTIONS
REGISTERED
Neo Nutritionals Inc
Brantford ON, CA N3S7X6 NOL-DO 112-2791188-3/1/1
54AYY99 791064357550 RECOVERY DRINK
20-JUN-2008 LIST INGRE
LACKS FIRM
A Couple Of Squares
London ON, CA N5W3R1 CIN-DO UPS-1502019-9/1/1
03JGT99 ICED SUGAR COOKIES
24-JUN-2008 UNSAFE COL
Biofine Internatio
Vancouver BRITISH COLUMBIA, CA V5L1L6 SAN-DO 112-2805001-2/1/1
66VIS99 791900363571 PIPERIDINE-3-CAROB
24-JUN-2008 NO LICENSE
Fun Energy Foods Inc
Markham CA-ON, CA L3R5Z2 NYK-DO UPS-1174208-5/1/1
54YCY99 KICKBUTT AMPED ENERGY BALLZ
25-JUN-2008 INCONSPICU
Body Blue Incorporated
Mississauga ON, CA L5S1B8 NYK-DO 300-2409862-4/2/1
62WBY99 Right Guard Xtreme Stealth
25-JUN-2008 NOT LISTED
Body Blue Incorporated
Mississauga ON, CA L5S1B8 NYK-DO 300-2409862-4/3/1
62WBY99 Right Guard Xtreme Stealth Fresh Blast
25-JUN-2008 NOT LISTED
Summer Fresh Salads Inc
Woodbridge ON, CA L4L8Z3 NYK-DO M76-7809019-3/1/1
39AHT01 COSTCO TUCSAN BEAN SALAD
25-JUN-2008 INSANITARY
A Couple Of Squares
London ON, CA N5W3R1 NOL-DO 112-0935119-9/1/1
03JGY99 859009282165 ICED COOKIES
25-JUN-2008 COLOR LBLG
LACKS N/C
Fortius Canada Inc
Charlottetown PE, CA C1C1P5 NYK-DO 551-7666962-5/1/1
54YCE07 RAZOR 8
25-JUN-2008 FALSE
Merck Frosst Canada, Ltd.
Kirkland QC, CA H9H3L1 NYK-DO 112-3196424-1/1/1
64UCA06 864291919061 PROPECIA 1MG TABLETS
26-JUN-2008 UNAPPROVED
Mastronardi Produce
Kingsville ON, CA N9Y2E5 DET-DO F57-2807588-1/5/1
24FGC20 Cucumbers
27-JUN-2008 PESTICIDE
1329729 Ontario Inc DBA Westmoreland Sales
Leamington Ontario, CA N8H3V5 DET-DO 112-3275599-4/2/1
24FGC20 Cucumbers
30-JUN-2008 PESTICIDE