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
Oakrun Farm Bakery Limited
Ancaster ON, CA L9G3L3 DET-DO 112-0217115-6/7/1
03RHN35 US SUPREME RASP RING DAN 8X1
03-DEC-2007 UNSAFE COL
COLOR LBLG
Oakrun Farm Bakery Limited
Ancaster ON, CA L9G3L3 DET-DO 112-0279413-0/1/4
03REN35 PREM RASP DANISH RING 8X1
03-DEC-2007 UNSAFE COL
COLOR LBLG
Master Delight Inc
Mississauga ON, CA L5S1V4 DET-DO 112-8580832-7/2/3A
33LHT07 Lokoum Mastika
03-DEC-2007 UNSAFE COL
Master Delight Inc
Mississauga ON, CA L5S1V4 DET-DO 112-8580832-7/2/3B
33LHT07 Lokoum Rose
03-DEC-2007 UNSAFE COL
Master Delight Inc
Mississauga ON, CA L5S1V4 DET-DO 112-8580832-7/3/1A
33KGT04 Malban Bulk w/Apricot & Pistachios
03-DEC-2007 UNSAFE COL
Master Delight Inc
Mississauga ON, CA L5S1V4 DET-DO 112-8580832-7/3/1B
33GGT12 Malban Bulk w/Sesame
03-DEC-2007 UNSAFE COL
Master Delight Inc
Mississauga ON, CA L5S1V4 DET-DO 112-8580832-7/3/1C
33GGT04 Malban Bulk w/Pistachios
03-DEC-2007 UNSAFE COL
Apollo Health And Beauty Care
Concord ON, CA L4K5M8 NOL-DO JG7-0810166-6/5/1
53LD-99 MIRACLE FACE LIFT
03-DEC-2007 CSTIC LBLG
A D I Drugs Limited
Toronto ON, CA M5N1B6 DET-DO 112-8894445-9/1/1
66VDY99 790370465309 AVANDIA
04-DEC-2007 DIRECTIONS
PERSONALRX
UNAPPROVED
Bluefield Associates, Inc.
Ontario , CA BLT-DO XXX-0152422-3/1/1A
66VBY99 Clear Essence Skin Beautifying Milk
05-DEC-2007 NOT LISTED
UNAPPROVED
Bluefield Associates, Inc.
Ontario , CA BLT-DO XXX-0152422-3/1/1O
66VBY99 Clear Essence Medicated Fade Cream
05-DEC-2007 NOT LISTED
UNAPPROVED
Korex Canada Limited
Etobicoke ON, CA M8Z2J8 NYK-DO WFN-8042027-2/1/1
53BH-01 BATH SALT
06-DEC-2007 CSTIC LBLG
Msp Inc Laboratories
Varennes QC, CA J3X1P7 NYK-DO WFN-8042027-2/2/1
53BY-02 Goat Milk Foaming Milk Bath
06-DEC-2007 CSTIC LBLG
Msp Inc Laboratories
Varennes QC, CA J3X1P7 NYK-DO WFN-8042035-5/2/1
53BY-02 FOAM BATH
06-DEC-2007 CSTIC LBLG
Korex Canada Limited
Etobicoke ON, CA M8Z2J8 NYK-DO WFN-8042035-5/1/1
53BH-01 BATH SALT
06-DEC-2007 CSTIC LBLG
Fun Energy Foods Inc
Markham CA-ON, CA L3R5Z2 NYK-DO M76-6091726-2/40/1
54YCY99 "Kickbutt" Amped Energy Ballz
06-DEC-2007 FALSE
COLOR LBLG
LABELING
NUTRIT LBL
Fg Nutraceutical
Vancouver BC, CA V6E4C4 NOL-DO 112-0245708-4/1/1
60QCJ67 BODY CREAM PROGESTERONE
07-DEC-2007 UNAPPROVED
Fg Nutraceutical
Vancouver BC, CA V6E4C4 NOL-DO 112-0245708-4/2/1
60QCJ67 Lidocaine (Anesthetic)
07-DEC-2007 UNAPPROVED
Easy Motion Horse Products Inc.
Grassie CA-ON, CA L0R1M0 NYK-DO BGK-0807451-1/5/1
62GPJ99 Montana Gel
10-DEC-2007 NEW VET DR
Easy Motion Horse Products Inc.
Grassie CA-ON, CA L0R1M0 NYK-DO BGK-0807451-1/6/1
62GPJ99 ENERGO
10-DEC-2007 NEW VET DR
Easy Motion Horse Products Inc.
Grassie CA-ON, CA L0R1M0 NYK-DO BGK-0807451-1/11/1
62GPJ99 EQUINE ORGAN
10-DEC-2007 NEW VET DR
Easy Motion Horse Products Inc.
Grassie CA-ON, CA L0R1M0 NYK-DO BGK-0807451-1/12/1
62GPJ99 EQUINE ORGAN
10-DEC-2007 NEW VET DR
Oakrun Farm Bakery Limited
Ancaster ON, CA L9G3L3 DET-DO 112-0396428-6/1/7
03REN35 US SUPREME RASP RING DAN 8X1
10-DEC-2007 UNSAFE COL
COLOR LBLG
Blair Smith
Thunder Bay ON, CA P7B5N3 NOL-DO 112-0364589-3/1/1
61KCS99 827509022060/SCOPOLAME
11-DEC-2007 UNAPPROVED
Eco-Med Pharmaceuticals Inc
Mississauga ON, CA L5S1S9 NOL-DO 112-0433791-2/3/1
90I--TX 792605285654 GEL
11-DEC-2007 NOT LISTED
Wyeth
Saint-Laurent QC, CA H4L2A5 NOL-DO 112-0496473-1/1/1
66VIP99 858955476313/ZOVIRAX/15G
11-DEC-2007 UNAPPROVED
Merck Frosst Canada, Ltd.
Kirkland QC, CA H9H3L1 NOL-DO 112-0490516-3/1/1
64UIB06 859201846352/MEDICATION
12-DEC-2007 UNAPPROVED
Ear Gear
Winfield BC, CA V4V1J2 NOL-DO 112-0480391-3/1/1
77E--SD 792605738836 HEARING AID PARTS
12-DEC-2007 NOT LISTED
Solarium Tanning
Leamington ON, CA N8H2Z7 NOL-DO 112-0433697-1/1/1
66BAQ44 850591983830 NICOTINE DELIVERY DEVICE-- Electronic Cigarette
12-DEC-2007 UNAPPROVED
Whitehall Robins Inc
Mississauga ON, CA L4Z3M6 NOL-DO 112-0492190-5/1/1
65QIB22 862162555446-ROBAXIN CAPLETS
13-DEC-2007 UNAPPROVED
Axcan Pharma Inc.
Mont-Saint-Hilaire QC, CA J3H4X8 NOL-DO 112-0578486-4/1/1
66VIP99 937271267120 MEZAVANT
13-DEC-2007 UNAPPROVED
Delon Laboratories
Dollard-Des-Ormeaux QC, CA H9B2N4 NYK-DO 336-5045819-6/8/1
53AD-01 BABY WASH
14-DEC-2007 POISONOUS
Delon Laboratories
Dollard-Des-Ormeaux QC, CA H9B2N4 NYK-DO 336-5045819-6/19/1
53AD-01 BABY SHAMPOO
14-DEC-2007 POISONOUS
Natural Performance
Deltadelta BRITISH COLUMBIA, CA V4G1L7 NYK-DO 110-0562038-6/1/1
54FEE99 "Male enhancement supplement"
14-DEC-2007 NUTRIT LBL
Szymon Investment Corporation
Mississauga CA-ON, CA L5E2N3 NYK-DO 551-5353566-6/1/1B
25QFT01 Mushroom Caps and Stems
14-DEC-2007 SOAKED/WET
FALSE
LABELING
Szymon Investment Corporation
Mississauga CA-ON, CA L5E2N3 NYK-DO 551-5353566-6/1/1A
25QFT01 Mushroom Caps on String
14-DEC-2007 FALSE
INSANITARY
LABELING
Canderm Pharma Ltd.
Saint-laurent QC, CA H4R2H4 NOL-DO 112-0493884-2/1/1
60QCY99 791806464360/BETACAINE
14-DEC-2007 NOT LISTED
UNAPPROVED
Fords Apothocary
Moncton NB, CA E1E2B5 NOL-DO 112-0537897-2/1/1
64GAF99 857912250102 ESTRIDOL 1MG
14-DEC-2007 UNAPPROVED
Fortius Inc
Charlottetown PE, CA C1C1P5 NOL-DO 112-0451232-4/1/1
66VBB99 859019110326 VEGGIE CAPSULE
18-DEC-2007 DIRECTIONS
DRUG NAME
Artron Bioresearch
Burnabyburnaby BRITISH COLUMBIA, CA V5J5H6 NOL-DO 112-0612974-7/1/1
82M--ZF 855502814139-HIV TEST KIT
18-DEC-2007 NOT LISTED
NO 510(K)
Solvay Pharma Inc
Columbia NEWFOUNDLAND, CA L3E0C9 NOL-DO 112-0572647-7/1/1
66SDP03 862564313415 SERC 24MG
18-DEC-2007 UNAPPROVED
Oakrun Farm Bakery Limited
Ancaster ON, CA L9G3L3 DET-DO 112-0587808-8/1/1
03REN25 PREM CHEESE DANISH RING 8X1
19-DEC-2007 INCONSPICU
Oakrun Farm Bakery Limited
Ancaster ON, CA L9G3L3 DET-DO 112-0587808-8/1/2
03REN25 PREM MAP WALNUT RING D 8X1
19-DEC-2007 INCONSPICU
Oakrun Farm Bakery Limited
Ancaster ON, CA L9G3L3 DET-DO 112-0587808-8/1/3
03REN25 PREM PECAN DAN. RING 8X1
19-DEC-2007 INCONSPICU
Oakrun Farm Bakery Limited
Ancaster ON, CA L9G3L3 DET-DO 112-0587808-8/1/4
03REN35 PREM RASP DANISH RING 8X1
19-DEC-2007 UNSAFE COL
INCONSPICU
COLOR LBLG
H.J. Heinz Co Of Canada
Leamington ON, CA N8H3A6 NYK-DO 144-0797353-9/1/1
40KCE03 Banana Graham pie babyfood custard
20-DEC-2007 TRANSFAT
NO PROCESS
H.J. Heinz Co Of Canada
Leamington ON, CA N8H3A6 NYK-DO 144-0797353-9/2/1
40DCE02 Creamed Corn babyfood.
20-DEC-2007 TRANSFAT
NO PROCESS
H.J. Heinz Co Of Canada
Leamington ON, CA N8H3A6 NYK-DO 144-0797353-9/3/1
40GCE01 Chicken with Broth baby food.
20-DEC-2007 TRANSFAT
NO PROCESS
Mainland Survival Supplies
Delta BC, CA V4K1J5 SEA-DO 110-1317192-7/1/1
79L--RR FIRST AID KITS
20-DEC-2007 NOT LISTED
REGISTERED
Our World Network Inc
Vancouver BC, CA V6E2M6 NOL-DO 112-0660313-9/1/1
54ABH99 863545802489 SUPPLEMENT
20-DEC-2007 NUTRIT LBL
Katch Kan Limited
Edmonton AB, CA T6H2J5 NOL-DO 112-0572771-5/2/1
85H--IS 858759069332/CODOMS
20-DEC-2007 NOT LISTED
NO 510(K)
Abbott Laboratories
Montreal QC, CA H3C3K6 NOL-DO 112-0657378-7/1/1
61MDP41 859019965210 DAPAKENE 250MG
20-DEC-2007 UNAPPROVED
Shoppers Drug Mart
Thornhill ONTARIO, CA L3T5W4 CIN-DO AEK-9067710-1/1/1
61BDB04 BICALUTAMIDE RX MEDICATION 50MG
21-DEC-2007 UNAPPROVED
Strub Brothers Limited
Brantford ON, CA N3R7K2 NYK-DO 144-0816804-8/1/1
24TCI08 Sauerkraut
21-DEC-2007 LACKS N/C
NUTRIT LBL
IND Diagnostic Inc.
Delta BC, CA V3M6S7 FLA-DO EQ6-0007102-9/1/1
81N--PR DNA TEST KITS FDA PLS ISSUE REFUSAL NOTICE IMMEDIATELY FOR E
26-DEC-2007 NOT LISTED
Voith Siemensc/O Delstar Energie
Montreal QUEBEC, CA H1A3N6 NYK-DO WRT-0084401-1/13/1
79L--RR KIT, FIRST AID;;
27-DEC-2007 NOT LISTED
Grande Prairie Family Dental
Grande Prairie ALBERTA, CA T8V2H6 NOL-DO 112-0685072-2/1/1
76E--LM 856379204008 DENTAL MODELS
27-DEC-2007 NOT LISTED
Swiss Herbal Remedies
Richmond Hill ON, CA L4B4C2 NOL-DO 112-0675934-5/2/1
66VCY99 858057634424/SHELCAL
27-DEC-2007 UNAPPROVED
Wings Foods Of Alberta
Edmonton AB, CA T6N1A3 SEA-DO 551-6100547-0/2/2
37JCI99 MINT CORIANDER SAUCE
27-DEC-2007 UNSAFE COL
Sanofi-Aventis Canada Inc.
Laval Quebec, CA H7L 4A8 MIN-DO XXX-0152977-6/1/1
61EDY06 Allegra Antihistamine (fexofenadine 120 mg tablets)
31-DEC-2007 UNAPPROVED
Sigan Industries Inc
Concord ON, CA L4K2M9 NYK-DO 390-4651593-6/1/1
62NBL99 T GEL PLUS SHAMPOO (ANTI-DANDRUFF)
31-DEC-2007 NOT LISTED
LABELING
Apollo Health And Beauty Care
Concord ON, CA L4K5M8 NYK-DO 390-4651593-6/2/1
53LD-06 HAND LOTION
31-DEC-2007 LABELING