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
Sanda Pastries Inc
Brossard Quebec, CA J4Y2P4 NYK-DO 551-7525112-8/4/1
03RFT01 Carrot Cake
01-OCT-2008 COLOR LBLG
Corey Feed Mills Ltd.
Fredericton New Brunswick, CA E3C 2G4 NWE-DO BLP-0150633-1/1/1
70MY-99 AQUA SEA FISH FEED 10MM 1000KG
02-OCT-2008 LIST INGRE
UNSAFE ADD
Corey Feed Mills Ltd.
Fredericton New Brunswick, CA E3C 2G4 NWE-DO BLP-0150633-1/1/4
70MY-99 AQUA SEA FISH FEED 3MM 25KG
02-OCT-2008 LIST INGRE
UNSAFE ADD
Corey Feed Mills Ltd
St. George CA-NB, CA E5C 3H7 NWE-DO BLP-0150628-1/1/2
70MY-99 AQUA SEA FISH FEED 7.5MM 1000KG
02-OCT-2008 LIST INGRE
UNSAFE ADD
Moulee Vallee Feed Inc
Canton Cleveland QC, CA J0B2H0 NWE-DO BLP-0015450-5/10/1
70MY-01 POMERLOW CALF
02-OCT-2008 LIST INGRE
FALSE
Corey Feed Mills Ltd.
Fredericton New Brunswick, CA E3C 2G4 NWE-DO BLP-0150667-9/1/2
70MY-99 AQUA SEA FISH FEED 7.5MM 1000KG
02-OCT-2008 LIST INGRE
UNSAFE ADD
Corey Feed Mills Ltd.
Fredericton New Brunswick, CA E3C 2G4 NWE-DO BLP-0150667-9/1/3
70MY-99 AQUA SEA FISH FEED 5MM 1000KG
02-OCT-2008 LIST INGRE
UNSAFE ADD
Corey Feed Mills Ltd.
Fredericton New Brunswick, CA E3C 2G4 NWE-DO BLP-0150646-3/1/4
70MY-99 AQUA SEA FISH FEED 5MM 1000KG
02-OCT-2008 LIST INGRE
UNSAFE ADD
Pharmetics, Niagara Operations
Fort Erie ONTARIO, CA L2A2S9 NOL-DO 112-4489619-0/1/1
54FYY12 799372240435 GINSENG POWDER
02-OCT-2008 LIST INGRE
KFI
BRAMPTON CA-ON, CA L5M5A4 NYK-DO 112-4365514-2/1/3
37JGO99 Tamarind Date Chutney Sauce - HOT & SPICY
03-OCT-2008 LIST INGRE
FALSE
PRESRV LBL
Body Plus
Scarborough ON, CA M1B3R6 NYK-DO 144-1972356-7/1/1
54CCR99 3308A US PROGRESSIVE HP PROTEIN 12 OZ VAN
06-OCT-2008 DIETARYLBL
UNSAFE ADD
NUTRIT LBL
Body Plus
Scarborough ON, CA M1B3R6 NYK-DO 144-1972356-7/1/2
54CCR99 3307A US PROGRESSIVE HP PROTEIN 12 OZ CHOC
06-OCT-2008 DIETARYLBL
UNSAFE ADD
NUTRIT LBL
David'S Greenhouse
Greely ON, CA K4P1N2 NYK-DO EG6-1576990-8/1/1
24FFC20 FRESH GREENHOUSE CUCUMBERS
08-OCT-2008 PESTICIDE
USUAL NAME
Fun Energy Foods Inc
Markham CA-ON, CA L3R5Z2 NYK-DO 112-4177876-3/1/1
54YCY99 KICKBUTT AMPED ENERGY BALLZ
09-OCT-2008 DIETARYLBL
Apotex Research In
North York ON, CA M9L2Z7 FLA-DO 112-4551897-5/4/1
62OCP13 865817675641 VERAPAMIL
09-OCT-2008 UNAPPROVED
Apotex Research In
North York ON, CA M9L2Z7 FLA-DO 112-4551897-5/4/3
60SCP22 865817675641 FAMOTIDINE
09-OCT-2008 UNAPPROVED
Apotex Research In
North York ON, CA M9L2Z7 FLA-DO 112-4551897-5/4/2
66MCP03 865817675641 ALPRAZOLAM
09-OCT-2008 UNAPPROVED
Squirrel Systems
Burnaby BC, CA V5A4V7 SAN-DO 112-4260427-3/1/1
95L--22 864283328680 POINT OF SALE
09-OCT-2008 NO REGISTR
Gourmet Du Village Morin Heights
Morin-Heights QC, CA J0R1H0 NYK-DO UPS-1259275-8/1/1
33EDT99 CANDY CANE
10-OCT-2008 UNSAFE COL
Allergan Pharmaceuticals Ireland
Mayo , IE NOL-DO 112-4548802-1/1/1
65QDN02 863547064157 BOTOX 100 Units
10-OCT-2008 PERSONALRX
NO ENGLISH
UNAPPROVED
Allergan Canada
Markham ON, CA L3R9S1 NOL-DO 112-4549216-3/1/1
65QDK02 863547064168 / BOTOX
10-OCT-2008 AGR RX
UNAPPROVED
Les Fermes Du Soleil Inc
Sainte Clotilde De Chateaugu Quebec, CA J0L1 NYK-DO EG6-1577210-0/2/1
25JFC04 GREEN ONIONS
14-OCT-2008 SHIGELLA
Les Fermes Du Soleil Inc
Sainte Clotilde De Chateaugu Quebec, CA J0L1 NYK-DO EG6-1577210-0/4/1
25JFC04 GREEN ONIONS
14-OCT-2008 SHIGELLA
Pharmalab (1982) Inc
Levis Qc, CA G6V6N6 NWE-DO UPS-0830747-6/1/1
54BEA01 CALCIUM TABLETS
14-OCT-2008 LIST INGRE
Cape Bald Packers Ltd
Cap-Pele Nb, CA E4N1E3 NWE-DO 551-6869781-6/1/1
16JGN01 FROZEN 5-8OZ SNOW CRAB SECTION
15-OCT-2008 SALMONELLA
Tanguay Stephanie
St-joseph-de-la-pointe-de-le QC, CA G6V6N4 CIN-DO UPS-2294218-7/1/1
62KIY10 OMEPRAZOLE, RX, NO ID, PER USE
16-OCT-2008 UNAPPROVED
Tanguay Stephanie
St-joseph-de-la-pointe-de-le QC, CA G6V6N4 CIN-DO UPS-2294218-7/1/2
66VCA99 LYRICA, RX, NO ID, PER USE
16-OCT-2008 UNAPPROVED
Tanguay Stephanie
St-joseph-de-la-pointe-de-le QC, CA G6V6N4 CIN-DO UPS-2294218-7/1/4
61NIY03 AMITRIPTYLINE, RX, NO ID, PER USE
16-OCT-2008 UNAPPROVED
Tanguay Stephanie
St-joseph-de-la-pointe-de-le QC, CA G6V6N4 CIN-DO UPS-2294218-7/1/5
65QIY01 BACLOFEN, RX, NO ID, PER USE
16-OCT-2008 UNAPPROVED
Tanguay Stephanie
St-joseph-de-la-pointe-de-le QC, CA G6V6N4 CIN-DO UPS-2294218-7/1/6
66JIY01 SYNTHROID, RX, NO ID, PER USE
16-OCT-2008 UNAPPROVED
Baxter Healthcare Corp
South Alliston ONTARIO, CA L0M1A0 CIN-DO UPS-2392715-3/1/1
66VCA99 MAGNESIUM SULFATE/NO RX/NO ID/PER USE/20 VIALS
16-OCT-2008 DRUG GMPS
UNAPPROVED
Carolanne Graham
Scarboroughscarborough ONTARIO, CA M1N1A2 CIN-DO UPS-2519742-5/1/1
61MCY38 LAMOTRIGINE/3/RX/NO ID/PER USE
16-OCT-2008 UNAPPROVED
Unifeed Limited-Lethbridge
Lethbridge CA-AB, CA R0G2L0 SEA-DO 144-1357475-8/1/1
70MY-01 BOSTOP DAIRY GRAIN RATION
17-OCT-2008 MFR INSAN
Eau Zone Oils & Fragrances Ltd
Montreal QC, CA H4N2S7 NYK-DO UPS-1260692-1/8/1
53BL-01 "Oriental Crystals: Scented Dead Sea Salt "Oceania"
20-OCT-2008 UNSAFE COL
LABELING
Eau Zone Oils & Fragrances Ltd
Montreal QC, CA H4N2S7 NYK-DO UPS-1260692-1/16/1B
53JD-01 Aphrodisiac Oil Orgy of Grapes
20-OCT-2008 LABELING
Eau Zone Oils & Fragrances Ltd
Montreal QC, CA H4N2S7 NYK-DO UPS-1260692-1/16/1D
53JD-01 Sensation Balm Blazing Cherry
20-OCT-2008 LABELING
Eau Zone Oils & Fragrances Ltd
Montreal QC, CA H4N2S7 NYK-DO UPS-1260692-1/16/1E
53JD-01 Shower Gel Exotic Fruits
20-OCT-2008 UNSAFE COL
LABELING
Eau Zone Oils & Fragrances Ltd
Montreal QC, CA H4N2S7 NYK-DO UPS-1260692-1/55/1
52BYY99 Massage cream labled as " tastes great "
20-OCT-2008 UNSAFE COL
LIST INGRE
FALSE
Renaissance Blends Corporation
Regina CA-SK, CA S4N3Y4 SEA-DO 144-1662423-0/1/1
28JGT99 SPICE BLENDS
21-OCT-2008 FILTHY
Sahin International Inc.
Etobicoke ON, CA M9W1P7 NYK-DO 112-4655500-0/4/1
28FCH99 SPECIALTY SPICE/AFGHAN SPICE
22-OCT-2008 LACKS N/C
NUTRIT LBL
Worldwide Air Couriers
Vancouver BC, CA V6B2L3 NOL-DO 112-1194450-2/1/1C
66VDF99 Yunnan Baiyao Capsules.
22-OCT-2008 UNAPPROVED
Worldwide Air Couriers
Vancouver BC, CA V6B2L3 NOL-DO 112-1194450-2/1/1D
54YGK04 Yunnan Paiyao
22-OCT-2008 LIST INGRE
Interactive Nutrition
Ottawa ON, CA K1V8B9 DET-DO 144-1802190-6/2/3
54CCR07 N.O.K.O. Fruit Punch
22-OCT-2008 UNSAFE COL
COLOR LBLG
Univet
Milton ON, CA L9T2Y5 NYK-DO EI5-5125061-2/8/1B
60SPR99 STOMA-COAT (ANTACID)
23-OCT-2008 LABELING
NEW VET DR
Univet
Milton ON, CA L9T2Y5 NYK-DO EI5-5125061-2/8/1C
60LPL07 WORK (MERCURIC CHLORIDE) VET USE
23-OCT-2008 LABELING
NEW VET DR
Ferme Choquette
St Alexandre QUEBEC, CA J0J1S0 NWE-DO UPS-0830254-3/1/1
70AY-02 YELLOW DENT CORN
23-OCT-2008 AFLATOXIN
Globalmed
Trenton ON, CA K8V6G7 DET-DO UPS-2595627-5/1/1
73C--AI 15MMX4" NAT. FLEX TUBE-DEL MEDEX LAREDO TX
24-OCT-2008 REGISTERED
Enviro Fresh Products
North York ON, CA M3J2C4 DET-DO M50-0006105-6/1/1
68YBL20 PLAQUE OFF FRESH BREATH
28-OCT-2008 WARNINGS
NEW VET DR
Enviro Fresh Products
North York ON, CA M3J2C4 DET-DO M50-0006105-6/1/2
68YBL20 PLAQUE OFF FRESH BREATH
28-OCT-2008 WARNINGS
NEW VET DR
Enviro Fresh Products
North York ON, CA M3J2C4 DET-DO M50-0006599-0/1/1
68YBL20 PLAQUE OFF FRESH BREATH
28-OCT-2008 WARNINGS
NEW VET DR
Enviro Fresh Products
North York ON, CA M3J2C4 DET-DO M50-0006599-0/2/1
68YBL20 PLAQUE OFF FRESH BREATH
28-OCT-2008 WARNINGS
NEW VET DR
Tri County Protein
Winchester ON, CA K0E1K0 NYK-DO 112-4856474-5/1/1
71LYY07 SOYA MEAL
28-OCT-2008 PESTICIDE
Champs De Vie Inc.
Plessisville QC, CA G6L2Y2 NYK-DO UPS-2502764-8/1/1
54ACA90 IsoPro-Vie Vanilla
29-OCT-2008 UNSAFE ADD
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156198-5/3/1
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156198-5/3/2
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156198-5/3/3
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156198-5/3/4
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156198-5/3/5
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156218-1/1/1
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156218-1/1/2
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156218-1/1/3
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156218-1/1/4
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156218-1/1/5
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156218-1/1/6
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156218-1/1/7
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156218-1/1/8
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156218-1/1/9
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/1
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/2
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/3
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/4
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/5
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/6
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/7
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/8
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/9
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/10
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/11
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Innovatech Designs
Montreal Quebec, CA H9G1L4 NYK-DO XXX-0156238-9/2/12
78L--KY Quick Extender Pro (Penile Enlargement Kit)
29-OCT-2008 NOT LISTED
DIRECTIONS
NO 510(K)
Maxim'S Bakery Ltd
Vancouver BC, CA V6A1X6 SEA-DO UPS-1056580-6/2/1
03AGT12 SWEET DINNER BUN
31-OCT-2008 FALSE
TRANSFAT
Maxim'S Bakery Ltd
Vancouver BC, CA V6A1X6 SEA-DO UPS-1056580-6/5/1
03AGT99 BLACK BEAN PASTE BUN
31-OCT-2008 FALSE
TRANSFAT