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
Joanne Adams
Okotoks AB, CA T1S1P6 CIN-DO AEK-9043369-5/1/1
61NCA29 PROZAC 20MG
02-NOV-2007 UNAPPROVED
Joanne Adams
Okotoks AB, CA T1S1P6 CIN-DO AEK-9043369-5/1/2
64GCA19 YASMIN 3MG
02-NOV-2007 UNAPPROVED
Odem International Inc
Rosemere QC, CA J7A3A7 SEA-DO 110-8023240-0/1/1
36CET04 RAW CAN WHITE HONEY/ODEM
05-NOV-2007 UNSAFE ADD
FILTHY
Advanced Orthomolecular Research
Calgary Ca-Ab, CA T2E 6X8 SEA-DO 310-1222111-1/5/1
54YCY99 "ORTHO IRON" FERRIC PYROPHOSPHATE DIETARY SUPPLEMENT
06-NOV-2007 FALSE
NUTRIT LBL
R.A.C. Medical Group, Inc.
Boca Raton, FL 33431-7963 DET-DO 110-0640179-4/1/1A
75J--MT Clarity Urocheck 4-OB
07-NOV-2007 REGISTERED
Diagnostic Test Group
Boca Raton, FL 33431-7966 DET-DO 110-0640179-4/1/1B
75N--BW Clarity Ketocheck
07-NOV-2007 REGISTERED
Diagnostic Test Group
Boca Raton, FL 33431-7966 DET-DO 110-0640179-4/4/1
75J--MT Clarity Urocheck Test Strips
07-NOV-2007 REGISTERED
Encore Gourmet Food Corp
Senneville QC, CA H9X4B4 NYK-DO EG6-1421615-8/1/1
36AHT99 CINNAMON SUGAR TOPPING-FDA PRODUCT CODE 36AHT99
07-NOV-2007 SALMONELLA
Apotex Research In
North York ON, CA M9L2Z7 NYK-DO 112-8824811-7/1/1
66VAY99 791418019586 PLACEBOS
07-NOV-2007 DIRECTIONS
Creation Technologies
Burnaby BC, CA V5J5H8 NOL-DO 112-8842163-1/1/1
74D--RQ 704354592990 MEDICAL STAMP AMPLIFIER
07-NOV-2007 NOT LISTED
NO 510(K)
Rodney Jacques
Calgary AB, CA T2J6S6 NOL-DO 112-8820967-1/1/1
64LCS56 862564736895/PREDNISON
07-NOV-2007 UNAPPROVED
Rodney Jacques
Calgary AB, CA T2J6S6 NOL-DO 112-8820967-1/2/1
61HCY43 862564736895/LEVOFLOXACIN
07-NOV-2007 UNAPPROVED
Europe Cosmetiques Inc
Saint Laurent QUEBEC, CA H4S1A7 NYK-DO EI5-8002734-6/1/1
54YYY99 ACTIVA C
08-NOV-2007 UNSAFE ADD
Encore Gourmet Food Corp
Senneville QC, CA H9X4B4 NYK-DO EG6-1381413-6/10/1
36AHT99 CINNAMON SUGAR, TOPPING (UPC-7645540140)
13-NOV-2007 SALMONELLA
Rocky Mountain Grain Production
Raymondraymond ALBERTA, CA T0K2S0 SEA-DO 110-0581139-9/1/1
23MGT99 PECAN HEMP SEED BAR
14-NOV-2007 LIST INGRE
LACKS N/C
NUTRIT LBL
HEALTH C
Level Ground Trading
Saanichton BC, CA V8M1Z6 SEA-DO AD1-0359464-5/3/1
21TGH99 DRIED PHYSALIS
15-NOV-2007 FALSE
LABELING
NUTRIT LBL
Les Emballages Knowlton Inc.
Knowlton QC, CA J0E1V0 NYK-DO 300-2246991-8/3/1
66VBJ99 MOISTURIZING (SKIN CARE PREPARATIONS);LIQUID, LOTION;
16-NOV-2007 NOT LISTED
Les Emballages Knowlton Inc.
Knowlton QC, CA J0E1V0 NYK-DO 300-2132528-5/2/1
66VBJ99 JOHN MELT AWAY STRESS LOTION
16-NOV-2007 NOT LISTED
Commercial Bakeries Corporation
North York ON, CA M3L1G5 NYK-DO 110-0576598-3/1/1
03JHT99 Maple Syrup Cream Cookies
19-NOV-2007 LIST INGRE
LACKS N/C
NUTRIT LBL
Vineland Growers
Jordan Station ON, CA L0R1S0 NYK-DO 390-4607294-6/9/1
20AHC09 GRAPES
20-NOV-2007 PESTICIDE
Paragon Vineyard
Jordan Station ON, CA L0R1S0 NYK-DO 112-8410409-0/1/1
20AFB09 GRAPES
20-NOV-2007 PESTICIDE
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0018821-9/1/1
65JDY29 LO-OVRAL TABS(END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0018821-9/2/1
64NCA04 FERROUS FUMARATE(IRON) END USER:WYETH
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019318-5/2/1E
65JDY29 LO-ORVAL TABS (END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019318-5/2/1D
65JDY29 LO-ORVAL TABS (END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019318-5/2/1C
65JDY29 LO-ORVAL TABS (END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019318-5/2/1B
65JDY29 LO-ORVAL TABS (END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019318-5/2/1A
65JDY29 LO-ORVAL TABS (END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019318-5/1/2
54BBY07 FERROUS FUMARATE 75MG TABS (END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019318-5/1/1
54BBY07 FERROUS FUMARATE 75MG TABS (END USER
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019162-7/1/1
65JDY29 LO-ORVAL TABLETS (END USER:WYETH) NOT FOR RESALE
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019478-7/1/1
65JDY29 LO-ORVAL TABLETS, (END USER:WYETH) ONLY IMPORTING FOR PACKAG
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019478-7/2/1
54BBY07 FERROUS FUMARATE
21-NOV-2007 UNAPPROVED
Glyco Bio Science Inc
Campbellville ON, CA L0P1B0 NYK-DO 110-8376435-9/1/1
80M--MS Intimate Feminine Lubricant
21-NOV-2007 REGISTERED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019687-3/1/1
65JDY29 LO-ORVAL TABLETS (END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019687-3/2/1
64NCA04 FERROUS FUMERATE 75MG TABLETS
21-NOV-2007 UNAPPROVED
Super Pufft
Mississauga ON, CA L5S1N8 NYK-DO 186-4008397-0/5/1
21VDF05 MANGO JUICE
21-NOV-2007 NO PROCESS
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019782-2/2/1
64NCA04 FERROUS FUMARATE (END USER
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019782-2/1/1
65JDY29 LO-ORVAL TABLETS (END USER
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019851-5/1/1
65JDY29 LO-ORVAL TABLETS(END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019894-5/1/1
65JDY29 LO-ORVAL TABLETS(END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0020075-8/2/1
64NCA04 FERROUS FUMARATE(END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0020075-8/1/1
65JDY29 LO-ORVAL TABLETS(END USER:WYETH)NOT FOR HUMAN USE
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0020252-3/1/1
65JDY29 LO-ORVAL TABLETS (END USER
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0020453-7/1/1
64NCA04 FERROUS FUMARATE(END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0020453-7/2/1
65JDY29 LO-ORVAL TABS(END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0020637-5/1/1
65JDY29 LO-ORVAL TABLETS
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0020778-7/1/1
64NCA04 FERROUS FUMARATE (END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0020778-7/2/1
65JDY29 LO-ORVAL TABLETS(END USER:WYETH)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0020887-6/1/1
65JDY29 LO-ORVAL TABLETS
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0021268-8/1/1
65JDY29 Lo-Orval Tablets
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0021268-8/2/1
64NCA04 Ferrous Fumarate 75mg Tablets
21-NOV-2007 UNAPPROVED
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 802-0018611-4/1/1
65JDY29 LO-OVRAL TABS(BEING BROUGHT IN FOR PACKAGING ONLY)
21-NOV-2007 UNAPPROVED
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 802-0018611-4/2/1
54BBY07 FERROUS FUMARATE (BEING IMPORTED FOR PACKAGING ONLY)
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019230-2/1/1A
65JDY29 LO-ORVAL (END USER:WYETH) ONLY IMPORTING FOR PACKAGING
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019230-2/1/1B
65JDY29 LO-ORVAL (END USER:WYETH) ONLY IMPORTING FOR PACKAGING
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019230-2/1/1C
65JDY29 LO-ORVAL (END USER:WYETH) ONLY IMPORTING FOR PACKAGING
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019230-2/1/1D
65JDY29 LO-ORVAL (END USER:WYETH) ONLY IMPORTING FOR PACKAGING
21-NOV-2007 UNAPPROVED
Wyeth
Saint-laurent QC, CA H4L5L5 NYK-DO 802-0019230-2/1/1E
65JDY29 LO-ORVAL (END USER:WYETH) ONLY IMPORTING FOR PACKAGING
21-NOV-2007 UNAPPROVED
Wyeth-Ayerst
Saint-Laurent QC, CA H4R1J6 NYK-DO EG6-1291087-7/1/1
65JDY29 LO OVRAL TABLETS
21-NOV-2007 UNAPPROVED
Wyeth-Ayerst
Saint-Laurent QC, CA H4R1J6 NYK-DO EG6-1291087-7/2/1
65JDY29 LO OVRAL TABS
21-NOV-2007 UNAPPROVED
Wyeth-Ayerst
Saint-Laurent QC, CA H4R1J6 NYK-DO EG6-1291087-7/3/1
65JDY29 LO OVRAL TABS
21-NOV-2007 UNAPPROVED
Wyeth-Ayerst
Saint-Laurent QC, CA H4R1J6 NYK-DO EG6-1291087-7/4/1
65JDY29 LO OVRAL TABS
21-NOV-2007 UNAPPROVED
Wyeth-Ayerst
Saint-Laurent QC, CA H4R1J6 NYK-DO EG6-1291087-7/5/1
65JDY29 LO OVRAL TABS
21-NOV-2007 UNAPPROVED
Rhema Industries Ltd
Coquitlam BC, CA V3K7B4 SEA-DO 144-0163580-3/4/3
54YCH04 MAGNUM HEAT DIETARY SUPPLEMENT
27-NOV-2007 SBGINSENG
NUTRIT LBL
Catalent
St Petersburg, FL 33716-1016 NYK-DO 802-0022164-8/1/1
62UAH11 ROBITUSSIN COUGHGELS(END USER:WYETH) OTC
28-NOV-2007 FALSE
Infra Ready
Saskatoon SK, CA S7K5Y8 NYK-DO 310-1152452-3/2/1
23KFH08 TOPPING, HARVEST SEED CDN
28-NOV-2007 LACKS N/C
NUTRIT LBL
Nisim International
Brampton ON, CA L6T4M4 NYK-DO 336-4229827-0/3/1
62NBL99 FAST SHAMPOO
28-NOV-2007 NOT LISTED
INCONSPICU
UNAPPROVED
Equipro
Montreal-Nord QC, CA H1G3K3 NYK-DO 551-7090139-6/10/1
76E--CC Glass Beads Sterilizer
28-NOV-2007 NOT LISTED
NO PMA/PDP
Lassonde Beverages Canada
Etobicoke CA-ON, CA M9W1L4 NYK-DO WRT-0084034-0/1/1
20SCO01 100 % Apple Juice From Concentrate
29-NOV-2007 LACKS N/C
Apple Valley Juice Corporation
Clarksburg ON, CA N0H1J0 NYK-DO 551-5365838-5/1/1
20SHO01 APPLE CIDER
29-NOV-2007 PATULIN
LACKS FIRM
Apple Valley Juice Corporation
Clarksburg ON, CA N0H1J0 NYK-DO 551-5365838-5/1/3
20DHT04 APPLE CRANBERRY JUICE
29-NOV-2007 LACKS FIRM
Univet
Milton ON, CA L9T2Y5 NYK-DO EI5-5486116-7/4/1
54AMR99 Stoma Coat
30-NOV-2007 NEW VET DR
Univet
Milton ON, CA L9T2Y5 NYK-DO EI5-5486116-7/13/1
54AMR99 Ultra H.A. with MSM
30-NOV-2007 NEW VET DR
Univet
Milton ON, CA L9T2Y5 NYK-DO EI5-5486116-7/12/1
54AMR99 Ultra Vigilant
30-NOV-2007 NEW VET DR