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
Iovate Health Sciences Mississauga ON, CA L4W5J5 NYK-DO F57-1389674-7/1/1A 41YYY99 NITRO-TECH HARDCORE WHEY PROTEIN FORMULA - VANILLA 05-MAR-2008 NUTRIT LBL Iovate Health Sciences Mississauga ON, CA L4W5J5 NYK-DO F57-1389674-7/1/1B 41YYY99 NITRO-TECH HARDCORE WHEY PROTEIN FORMULA - STRAWBERRY 05-MAR-2008 LIST INGRE NUTRIT LBL Bayshore Specialities Ltd. Oakville CA-ON, CA L6H5S4 NYK-DO 551-7352027-6/1/1 29BGT99 FUELCELL Energy Drink "Wild Berry" 06-MAR-2008 LIST INGRE Instant Foods ltd. Scarborough CA-ON, CA M1V4Z7 LOS-DO HA9-0800003-7/4/2 07YGT99 GLUCORASA (SNACK) 06-MAR-2008 UNSAFE COL LIST INGRE LACKS N/C TRANSFAT NUTRIT LBL YELLOW #5 Centre D Affaires Core Montreal QUEBEC, CA H4A1E9 NOL-DO 112-0102997-5/1/1 79L--RW 849498761508/SCISSOR 06-MAR-2008 NOT LISTED Thomas Haas Fine Chocolates North Vancouver BC, CA V7P3T2 NOL-DO 112-0122847-8/1/1 33BGT99 792593652564-CHOCOLATE CANDY 06-MAR-2008 LACKS FIRM NUTRIT LBL Xl Meats Calgary AB, CA T2H1M7 SEA-DO 112-6421945-1/1/1 71AYY01 INEDIBLE BEEF PRODUCTS 07-MAR-2008 MFR INSAN Blue Orchid Waters Inc. Saint-jean-sur-richelieu CA-QC, CA J3B8J8 NYK-DO 110-7447155-0/1/1 29WHT01 BOTTLED WATER 10-MAR-2008 MFR INSAN USUAL NAME Castleguard Health Services Limited Paris ON, CA N3L3J4 NYK-DO 186-1306379-3/1/1 54FCE99 ALLERGY RELIEF 10-MAR-2008 DIETARYLBL NUTRIT LBL Castleguard Health Services Limited Paris ON, CA N3L3J4 NYK-DO 186-1306379-3/2/1 54FCE99 CARPAL TUNNEL SYNDROME 10-MAR-2008 DIETARYLBL NUTRIT LBL Castleguard Health Services Limited Paris ON, CA N3L3J4 NYK-DO 186-1306379-3/3/1 54FCE99 SUPER IQ 10-MAR-2008 DIETARYLBL NUTRIT LBL Ponderosa Trading Co Ltd Port Coquitlam BC, CA V3C5M5 SEA-DO 112-5398270-5/3/1 25QFH06 DRIED MOREL MUSHROOMS 10-MAR-2008 FILTHY Thomas Haas Fine Chocolates North Vancouver BC, CA V7P3T2 NOL-DO 112-0122816-3/1/1 33BGT99 798303236609-CHOCOLATE CANDY 10-MAR-2008 LACKS FIRM NUTRIT LBL Ralph & Sandra Gehmlich Okotoks AB, CA T1S1G9 SEA-DO UPS-0236586-2/1/1 66VCS99 PRESCRIPTION DRUG ACCUTANE STUDENT 12-MAR-2008 UNAPPROVED Sahin International Inc. Etobicoke ON, CA M9W1P7 NYK-DO 112-1417990-8/3/1 04CGT02 CRISPY NOODLE 12-MAR-2008 YELLOW #5 Sahin International Inc. Etobicoke ON, CA M9W1P7 NYK-DO 112-1417990-8/3/2 04CGT02 CRISPY NOODLE 12-MAR-2008 YELLOW #5 Unique Foods Limited Concord ON, CA L4K4G3 NYK-DO 144-1375397-4/1/1A 27YCI03 Bhel Chutney 12-MAR-2008 FILTHY Unique Foods Limited Concord ON, CA L4K4G3 NYK-DO 144-1375397-4/1/1D 27YCI03 Date Chutney 12-MAR-2008 FILTHY Unique Foods Limited Concord ON, CA L4K4G3 NYK-DO 144-1375397-4/1/1I 27YCI03 Sweet and Sour Somosa Chutney 12-MAR-2008 FILTHY Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1A 61NCC76 Unexetin 13-MAR-2008 UNAPPROVED Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1B 62KCC10 Omeprazole 13-MAR-2008 UNAPPROVED Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1C 62OCC44 Merol-25 mg tablets 13-MAR-2008 UNAPPROVED Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1D 66TCC01 Zyloric 13-MAR-2008 UNAPPROVED Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1E 62GCC48 Unistan 13-MAR-2008 UNAPPROVED Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1F 61XCC45 Baydal 13-MAR-2008 UNAPPROVED Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1G 60CCC57 Unitamol 13-MAR-2008 UNAPPROVED Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1H 60CCC57 Cofcol 13-MAR-2008 UNAPPROVED Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1I 60XCC17 Tenormin 13-MAR-2008 UNAPPROVED Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1J 56BCC03 Amoxil 13-MAR-2008 UNAPPROVED Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1K 61NCC65 Uniprime 13-MAR-2008 UNAPPROVED Unaiza Rana Mississaugamississauga ONTARIO, CA L5M4Z9 CIN-DO UPS-0165435-7/1/1L 61JCC14 Bestatin 13-MAR-2008 UNAPPROVED Tri Nguyen North York ON, CA M9M1R4 DET-DO UPS-0160931-0/1/1 66VCL99 Chinese Medicine 13-MAR-2008 DIRECTIONS LACKS FIRM INCONSPICU UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0022378-4/1/1 65JDY29 LO-ORVAL TABLETS (END USER:WYETH) 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0022478-2/1/1 64NCA04 FERROUS FUMURATE(END USER:WYETH) 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0022478-2/2/1 65JDY29 LO-ORVAL TABLETS(END USER:WYETH) 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0022749-6/1/1 64NCA04 FERROUS FUMARATE (END USER:WEYTH) 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0022749-6/2/1 65JDY29 LO-ORVAL TABLETS(END USER:WYETH) 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0022969-0/1/1 65JDY29 LO-ORVAL TABLETS(END USER:WYETH) 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0023042-5/1/1 64NCA04 FERROUS FUMURATE(END USER:WYETH) 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0023042-5/2/1 65JDY29 LO-ORVAL TABLETS (END USER:WYETH) 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0023106-8/1/1 65JDY29 LO-ORVAL TABLETS(END USER:WYETH) 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0023299-1/1/1 65JDY29 LO-ORVAL TABLETS 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0023299-1/2/1 64NCA04 FERROUS FUMARATE 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0023339-5/1/1 65JDY29 LO-ORVAL TABLETS 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0023451-8/1/1 65JDY29 LO-OVRAL TABLETS 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0023174-6/1/1 64NCA04 FERROUS FUMARATE 75 MG TABS (END USER: WYETH) 13-MAR-2008 UNAPPROVED Wyeth Canada Saint-laurent QC, CA H4R1J6 NYK-DO 802-0023174-6/2/1 65JDY29 LO-OVRAL TABLETS (END USER:WYETH) NOT FOR HUMAN USE 13-MAR-2008 UNAPPROVED Norwood Packaging Ltd. Surrey British Columbia, CA V3W 4N8 DET-DO UPS-0158378-8/1/1C 65LBL99 Daily Protection SPF 30 14-MAR-2008 NOT LISTED UNAPPROVED Bonduelle Canada Inc Saint-denis-sur-richelieu CA-QC, CA J0H1K0 NYK-DO 300-2393052-0/1/1 24AEE51 PEAS 17-MAR-2008 NEEDS FCE NO PROCESS Bonduelle Canada Inc Saint-denis-sur-richelieu CA-QC, CA J0H1K0 NYK-DO 300-2393052-0/2/1 24AEE51 PEAS 17-MAR-2008 NEEDS FCE NO PROCESS Shawn Kalke Edmontonedmonton ALBERTA, CA T6M1B4 CIN-DO UPS-0434230-7/2/1 65QDA22 MUSCLE RELAXER, OTC, US CITIZEN, PER USE 19-MAR-2008 UNAPPROVED Advanced Orthomolecular Research Calgary Ca-Ab, CA T2E 6X8 SEA-DO M76-8784533-0/3/1 54FBE99 GHANDA 750 STANDARDIZED WITHANIA SOMNIFERA DIETARY SUPPLEMEN 19-MAR-2008 SBGINSENG Advanced Orthomolecular Research Calgary Ca-Ab, CA T2E 6X8 SEA-DO M76-8784533-0/7/1 66VAE99 NATTOKINASE 19-MAR-2008 UNAPPROVED Oconnell John Tofing BRITISH COLUMBIA, CA V0R2Z0 LOS-DO AEK-7960418-3/1/1 63BDY01 ALBUTEROL INHALER (FORMAL ENTRY REQUESTED BY FDA) 19-MAR-2008 UNAPPROVED Oconnell John Tofing BRITISH COLUMBIA, CA V0R2Z0 LOS-DO AEK-7960418-3/2/1 62CDY65 LISINOPRIOL(FORMAL ENTRY REQUESTED BY FDA) 19-MAR-2008 UNAPPROVED Oconnell John Tofing BRITISH COLUMBIA, CA V0R2Z0 LOS-DO AEK-7960418-3/3/1 64BDY25 HYDROCHLORAT(FORMAL ENTRY REQUESTED BY FDA) 19-MAR-2008 UNAPPROVED Grand River Gourment Cambridge ON, CA N1T1A1 NYK-DO 144-1400543-2/1/1 34KYY04 Heart Chocolate Chocolate Bar 20-MAR-2008 LABELING Wyeth Canada Ontario ONTARIO, CA H4R1J6 NOL-DO 112-1721817-4/2/1 66VIP99 929420369902 OVRAL 500MG 20-MAR-2008 UNAPPROVED Ramico Foods Inc Saint-Leonard QC, CA H1P2A2 NYK-DO EG6-1452686-1/30/1 24AEE05 LAZIZA BRAND FAVA BEANS W/CHILI 21-MAR-2008 LACKS N/C NUTRIT LBL NO PROCESS Ramico Foods Inc Saint-Leonard QC, CA H1P2A2 NYK-DO EG6-1452686-1/31/1 24AEE05 LAZIZA BRAND FAVA BEANS W/CUMIN 21-MAR-2008 LACKS N/C NUTRIT LBL NO PROCESS Mega Corp Int'L Marketing Concord ON, CA L4K4M2 CIN-DO UPS-0315976-9/1/1 54AAC99 ERR- BLITZ- HERBAL VITAMINS- NO INGREDIANTS, BUSTED OPEN IN 25-MAR-2008 FILTHY INCONSPICU Craft Canada Mont-Royal QC, CA H4P2K9 NYK-DO 300-2542248-4/1/1 12AGT06 MARBLE CHEDDAR CHEESE 25-MAR-2008 LIST INGRE LACKS N/C NUTRIT LBL CanGro Foods Inc. Exeter CA-ON, CA N0M1S2 NYK-DO 300-2477877-9/1/1 24AEE60 UNLABELED WHOLE KERNEL CRISP CORN 26-MAR-2008 INCONSPICU Cangro Foods Inc Toronto ON, CA M8V1A3 NYK-DO 300-2534057-9/1/1 24AEE60 UNLABELED WHOLE KERNEL CRISP CORN 26-MAR-2008 INCONSPICU Nisim International Brampton ON, CA L6T4M4 NYK-DO 336-4242534-5/1/1A 53ED-06 SHAMPOO 2 oz 26-MAR-2008 COSMETLBLG Nisim International Brampton ON, CA L6T4M4 NYK-DO 336-4242534-5/1/1B 53ED-06 SHAMPOO 8 oz 26-MAR-2008 COSMETLBLG Nisim International Brampton ON, CA L6T4M4 NYK-DO 336-4242534-5/1/1E 53ED-06 SHAMPOO SAMPLES 26-MAR-2008 COSMETLBLG Nisim International Brampton ON, CA L6T4M4 NYK-DO 336-4242534-5/2/1A 53EY-01 HAIR CONDITIONER 8 oz 26-MAR-2008 COSMETLBLG Nisim International Brampton ON, CA L6T4M4 NYK-DO 336-4242534-5/2/1B 53EY-01 HAIR CONDITIONER Litre 26-MAR-2008 COSMETLBLG Nisim International Brampton ON, CA L6T4M4 NYK-DO 336-4242534-5/2/1C 53EY-01 FAST CONDITIONER 26-MAR-2008 COSMETLBLG Nisim International Brampton ON, CA L6T4M4 NYK-DO 336-4242534-5/2/1D 53EY-99 HAIR LOSS SURVIVAL KIT 26-MAR-2008 COSMETLBLG Nisim International Brampton ON, CA L6T4M4 NYK-DO 336-4242534-5/3/1A 53EY-99 HAIR AND SCALP EXTRACTS 26-MAR-2008 COSMETLBLG Nisim International Brampton ON, CA L6T4M4 NYK-DO 336-4242534-5/4/1 53ED-99 KALO INGROWN HAIR TREATMENT 26-MAR-2008 COSMETLBLG SPC Inc Ottawa ON, CA K1V1A8 NYK-DO XXX-0153518-7/1/1 54YCF99 RLS-H Dietary Supplement 26-MAR-2008 DIETARYLBL NUTRIT LBL HEALTH C Western Safety Products Port Moody BC, CA V3H1X2 SEA-DO UPS-0314058-7/1/1 79L--RR LEVEL2 FIRST AID BAG W CONTENTS 26-MAR-2008 NOT LISTED Western Safety Products Port Moody BC, CA V3H1X2 SEA-DO UPS-0314058-7/23/1 89I--ME INSTANT COLD PACKS 26-MAR-2008 NOT LISTED Pharmascience Inc. Montreal QC, CA H4P2T4 NYK-DO 551-7643123-2/1/1 61NDR69 GABAPENTIN (ANTI-DEPRESSANT);HUMAN - RX/COMBINATION INGREDIE 27-MAR-2008 NOT LISTED UNAPPROVED Les Emballages Knowlton Inc. Knowlton QC, CA J0E1V0 NYK-DO 300-2430124-2/1/1 66VBJ99 Aveeno Eczema Care Cream 28-MAR-2008 NOT LISTED UNAPPROVED Roche Canada Montreal QUEBEC, CA H1E2V6 NOL-DO 112-1777986-0/1/1 62GIA50 799283518609 / NAPROXEN 28-MAR-2008 UNAPPROVED Enermark Calgary ALBERTA, CA T2P2Z1 NOL-DO 112-1824300-7/1/1 79L--RR 799815636360/FIRST AID KIT 28-MAR-2008 NOT LISTED Sandoz Canada Inc Boucherville QC, CA J4B7K8 NOL-DO 112-1844547-9/1/1 61GCY06 858927961196.OPTIMYXIN 28-MAR-2008 UNAPPROVED Galderma Production Canada, Inc. Baie-D'Urfe Quebec, CA H9X 3N7 NOL-DO 112-1926358-2/1/1 62LCJ50 858923628973 METROGEL 28-MAR-2008 PERSONALRX Roderick L Decouto Real Estate Ltd Hamiltonhamilton , BM 02000 CIN-DO UPS-0294326-2/1/1 64XCA11 ACNE MEDICATION CALLED ACCUTANE TABLETS/1/RX/FOR PERSONAL US 28-MAR-2008 UNAPPROVED CanGro Foods Inc. Exeter CA-ON, CA N0M1S2 NYK-DO 300-2505111-9/1/1 24AEE60 CORN REG 24 X 15 0Z 28-MAR-2008 NEEDS FCE NO PROCESS Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/1 34FGT08 BUNNY 1 FOOT 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/3 34FGT08 BUNNY HOLLOW 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/4 34FGT08 BUNNY MINI POP 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/5 34FGT08 MIX EASTER 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/6 34FGT08 CARROT BUN HEAD POP 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/7 34FGT08 BUNNY 1 FOOT 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/9 34FGT08 BUNNY HOLLOW 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/10 34FGT08 BUNNY MINI POP 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/11 34FGT08 MIX EASTER CLASSIC BUNNY 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/12 34FGT08 MIX EASTER 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/13 34FGT08 CARROT/BUN HEAD POP 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/14 34FGT08 BUNNY 1 FOOT 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/15 34FGT08 BUNNY 1 FOOT 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/17 34FGT08 BUNNY HOLLOW 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/18 34FGT08 BUNNY MINI POP 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/19 34FGT08 MIX EASTER CLASSIC BUUNY 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/21 34FGT08 CARROT/BUN HEAD POP 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/22 34FGT08 BUNNY 1 FOOT 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/24 34FGT08 MIX EASTER CLASSIC BUNNY CHOC 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/25 34FGT08 CARROT/BUN HEAD POP 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/28 34FGT08 BUNNY HOLLOW 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/29 34FGT08 BUNNY HOLLOW 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/30 34FGT08 BUNNY MINI POP 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/33 34FGT08 CARROT/BUN HEAD POP 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/20 34FGT08 CARROTS POP 31-MAR-2008 UNSAFE COL NUTRIT LBL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/26 34FGT08 HOLLOW MILK CHO. BUNNY 31-MAR-2008 UNSAFE COL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/31 34FGT08 MILK CLASSIC BUNNY 31-MAR-2008 UNSAFE COL NUTRIT LBL Splendid Chocolates Inc Montreal QC, CA H4P2N5 NYK-DO 551-7347086-0/1/32 34FGT08 BUNNY W/FLOWER POP 31-MAR-2008 UNSAFE COL NUTRIT LBL