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
Vimex Pharma Inc
Ilderton ON, CA N0M2A0 NYK-DO 110-1441369-0/1/1
63VBJ99 HIRUVAL 35 CREAM
01-FEB-2008 NOT LISTED
Schering Canada Inc.
Pointe-claire QC, CA H9R1B4 NYK-DO 300-2376569-4/1/1
61JIA15 EZETROL
04-FEB-2008 UNAPPROVED
Brookside Farms, Ltd.
Abbotsford BC, CA V2T6H1 NYK-DO M76-3708802-3/24/1
34GGT02 DARK CHOCOLATE CRANBERRIES
05-FEB-2008 LACKS N/C
Pharmacie Sylvie Champagne
Quebec QC, CA G1T1Z2 CIN-DO 110-1525619-7/1/1
65PCA03 FLOMAX CR , RX, NO ID, PER USE
06-FEB-2008 UNAPPROVED
Pharmacie Sylvie Champagne
Quebec QC, CA G1T1Z2 CIN-DO 110-1525619-7/1/3
66VCA99 AVANDIA 8MG, RX,NO ID, PER USE
06-FEB-2008 UNAPPROVED
Pharmacie Sylvie Champagne
Quebec QC, CA G1T1Z2 CIN-DO 110-1525619-7/1/4
66VCA99 ASAPHEN E.C. 80MG, RX,NO ID, PER USE
06-FEB-2008 UNAPPROVED
Pharmacie Sylvie Champagne
Quebec QC, CA G1T1Z2 CIN-DO 110-1525619-7/1/5
66VCA99 LYTICA 150 MG , RX,NO ID, PER USE
06-FEB-2008 UNAPPROVED
Pharmacie Sylvie Champagne
Quebec QC, CA G1T1Z2 CIN-DO 110-1525619-7/1/6
62OCA03 COVERSYL 2 MG, RX,NO ID, PER USE
06-FEB-2008 UNAPPROVED
Pharmacie Sylvie Champagne
Quebec QC, CA G1T1Z2 CIN-DO 110-1525619-7/1/7
66VCA99 NOVO-QUININE 300 MG, RX,NO ID, PER USE
06-FEB-2008 UNAPPROVED
Pharmacie Sylvie Champagne
Quebec QC, CA G1T1Z2 CIN-DO 110-1525619-7/1/8
61PCA11 NOVO-GLYBURIDE 5 MG, RX,NO ID, PER USE
06-FEB-2008 UNAPPROVED
Pharmacie Sylvie Champagne
Quebec QC, CA G1T1Z2 CIN-DO 110-1525619-7/1/9
66VCA99 NOVO-SEMIDE, RX,NO ID, PER USE
06-FEB-2008 UNAPPROVED
Viva Natural Source Inc
Richmond BC, CA V6V3B6 SEA-DO 110-1541815-1/1/1
54GBR04 SHARK CARTILAGE
07-FEB-2008 FILTHY
Comsetic Skin Clinic
Sherwood Park ALBERTA, CA T8A4W3 NOL-DO 112-1135751-5/1/1
53LD-03 836874740320/LOTION
07-FEB-2008 FALSE
Pharmalab
Levis QUEBEC, CA G6V8N6 NWE-DO EG6-1385779-6/6/1
41GET02 WILDBERRY YOGURT FLAVOURED DRINK MIX
07-FEB-2008 DIETARYLBL
HEALTH C
Pharmalab
Levis QUEBEC, CA G6V8N6 NWE-DO EG6-1386085-7/1/1
41GET02 POMERGRANTE JUICE X
07-FEB-2008 UNSAFE ADD
Pharmalab
Levis QUEBEC, CA G6V8N6 NWE-DO EG6-1386085-7/5/1
41GET02 PEACH & MANGO FLAVOURED DRINK
07-FEB-2008 UNSAFE ADD
Pharmalab
Levis QUEBEC, CA G6V8N6 NWE-DO EG6-1386085-7/25/1
41GET02 PEACH & MANGO FLAVOURED DRINK
07-FEB-2008 UNSAFE ADD
Pharmalab
Levis QUEBEC, CA G6V8N6 NWE-DO EG6-1386085-7/39/1
41GET02 LEMON FLAVOURED PUDDING
07-FEB-2008 UNSAFE ADD
Pharmalab
Levis QUEBEC, CA G6V8N6 NWE-DO EG6-1386085-7/40/1
41GET02 LEMON FLAVOURED PUDDING
07-FEB-2008 UNSAFE ADD
Lise Watier Cosmetiques Inc
Montreal QC, CA H4T1B4 NOL-DO 112-1199891-2/1/1
53YY-99 858511376056 MAKEUP EYES
07-FEB-2008 COSMETLBLG
Cobalt Pharmaceuticals, Inc.
Mississauga Ontario, CA L5N 2B8 NOL-DO 112-1205365-9/1/1
61PAA26 863547700497/METFORMIN 500MG
07-FEB-2008 UNAPPROVED
Harbers Pharmacy
Barrie ONTARIO, CA L4M4Y8 NOL-DO 112-1289819-4/1/1
64GDA28 864285587209 PROVITAMINS
07-FEB-2008 UNAPPROVED
Dr Goodpet
Inglewood, CA 90302-3102 SEA-DO XXX-0153121-0/1/1
66VAL99 Dr Goodpet Scratch Free
08-FEB-2008 NEW VET DR
Herbs For Horse
Guelph ON, CA N1H1E9 NYK-DO M76-8709709-8/2/1
70MY-02 LIVER HEALTH
11-FEB-2008 NEW VET DR
Herbs For Horse
Guelph ON, CA N1H1E9 NYK-DO M76-8709709-8/3/1
70MY-02 ALL IN ONE
11-FEB-2008 MFR INSAN
Nisim International
Brampton ON, CA L6T4M4 NYK-DO 110-1488713-3/1/1
53ED-99 NISIM HAIR STIMULATING EXTRACT
12-FEB-2008 CSTIC LBLG
Nisim International
Brampton ON, CA L6T4M4 NYK-DO 110-1488713-3/2/1
53ED-06 NISIM DEEP CLEANSING SHAMPOO
12-FEB-2008 CSTIC LBLG
Sakai Spice Canada Corp.
Lethbridge AB, CA T1H0C8 NYK-DO 300-2475088-5/5/1
26AYY12 MUSTARD OIL INDUSTRIAL
12-FEB-2008 UNSAFE ADD
Merck Frosst Canada, Ltd.
Kirkland QC, CA H9H3L1 NYK-DO 112-1077269-8/1/1
64UIY06 863547857054 PROSCAR 5mg tablets
13-FEB-2008 UNAPPROVED
Natural Factors
Coquitlam British Columbia, CA V3k 6Y7 SEA-DO UPS-0561121-9/4/6
54YCR99 REVITALX & DETOXITECH KIT
13-FEB-2008 NUTRIT LBL
UNAPPROVED
Matol Botanical International Ltd
Pointe-Claire QUEBEC, CA H9R6R6 NYK-DO 300-2377762-4/1/1
65JAJ31 PROGESTERONE CREAM
13-FEB-2008 NOT LISTED
DIRECTIONS
UNAPPROVED
Matol Botanical International Ltd
Pointe-Claire QUEBEC, CA H9R6R6 NYK-DO 300-2377802-8/1/1
65JBJ31 PROGESTERONE CREAM
13-FEB-2008 NOT LISTED
DIRECTIONS
UNAPPROVED
GlaxoSmithKline Inc.
Mississauga Ontario, CA L5N 6L4 CIN-DO 110-1502430-6/2/1
61NCA05 ZYBAN/NO RX/NO ID/PER USE
14-FEB-2008 UNAPPROVED
Boehringer Ingelheim Canada
Burlington ON, CA L7L5H4 CIN-DO 110-1558780-7/1/1
63BQL35 VENTIPULMIN, HORSE MEDICINE, FOR VET USE ONLY
15-FEB-2008 DIRECTIONS
Chris' Canine Crunchies
Burlington CA-ON, CA L7L5V2 NYK-DO D03-0160710-3/4/1
72BGY99 HOLISTIC CHOMP MUNCHIES-PET TREATS
15-FEB-2008 MFR INSAN
Chris' Canine Crunchies
Burlington CA-ON, CA L7L5V2 NYK-DO D03-0160710-3/5/1
72BGY99 OMEGA SAUCE-PET FOOD TOPPING
15-FEB-2008 MFR INSAN
Point Queen Fisheries Ltd
Lord'S Cove NB, CA E5V1W2 NWE-DO 551-6451320-7/1/1
16EAC02 CLAMS;FABRIC;RAW, FRESH, REFRIGERATED
15-FEB-2008 INSANITARY
Almac Clinical Services, Inc.
Audubon, PA 19403-2413 NYK-DO M76-8705177-2/1/1
66VIA99 CONTRAVE
19-FEB-2008 UNAPPROVED
SPC Inc
Ottawa ON, CA K1V1A8 NYK-DO 110-1733201-2/1/1
54YCH99 DIETARY SUPPLMENT-RESTLESS LEGS
22-FEB-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
SPC Inc
Ottawa ON, CA K1V1A8 NYK-DO 110-1733651-8/1/1
54YCH99 DIETARY SUPPLMENT-RESTLESS LEGS
22-FEB-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
SPC Inc
Ottawa ON, CA K1V1A8 NYK-DO UPS-0014098-6/1/1
54YCH99 DIETARY SUPPLEMENT RESTLESS LEG SYNDROME
22-FEB-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
SPC Inc
Ottawa ON, CA K1V1A8 NYK-DO UPS-0049562-0/1/1
54FCH16 RLS-H Restless Legs (Extra Strength Formula)
22-FEB-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
Master Delight Inc
Mississauga ON, CA L5S1V4 NYK-DO 112-1061693-7/4/1
23AGT11 ROASTED SALTED PISTACHIOS
25-FEB-2008 AFLATOXIN
USUAL NAME
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 110-7552290-6/1/1
60CIE02 SLV 351 CAPS DEVELOPMENT STATEMENT FOR SCHIZOPHRENIA
26-FEB-2008 UNAPPROVED
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 110-7552290-6/2/1
60CIE02 SLV 351 CAPS DEVELOPMENT FOR TREATMENT OF SCHIZOPHRENIA
26-FEB-2008 UNAPPROVED
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 110-7552290-6/3/1
60CIE02 SLV 351 CAPS INDEVELOPMENT FOR TREATMENT OF SCHIZOPHRENIA
26-FEB-2008 UNAPPROVED
Wyeth Canada
Saint-laurent QC, CA H4R1J6 NYK-DO 110-7552290-6/4/1
55YP-99 PLACEBO FOR SLV-351
26-FEB-2008 UNAPPROVED
Aloka Co., Ltd.
Tokyo , JP 181 NOL-DO 112-0078674-0/1/1
90I--TX 844320737372 ULTRASOUND PROBE
26-FEB-2008 FAILS STD
Wyeth Consumer Hea
Mississauga ON, CA L4Z3M6 SAN-DO 112-1554853-1/1/1
60LBH01 864283998259 ROBAXACET
27-FEB-2008 NOT LISTED
SPC Inc
Ottawa ON, CA K1V1A8 NYK-DO UPS-0147381-6/1/1
54FCH16 RESTLESS LEG DIETARY SUPPLEMENT
28-FEB-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
SPC Inc
Ottawa ON, CA K1V1A8 NYK-DO UPS-0170508-4/1/1
54FCH16 RLS-H (Restless Leg Syndrome)
28-FEB-2008 NUTRIT LBL
HEALTH C
SPC Inc
Ottawa ON, CA K1V1A8 NYK-DO UPS-0170701-5/1/1
54FCH16 RLS-H (Restless Leg Syndrome)
28-FEB-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
SPC Inc
Ottawa ON, CA K1V1A8 NYK-DO UPS-0174637-7/1/1
54FCH16 RLS-H (Restless Leg Syndrome)
28-FEB-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
SPC Inc
Ottawa ON, CA K1V1A8 NYK-DO UPS-0200723-3/1/1
54FCH16 RLS-H (Restless Leg Syndrome)
28-FEB-2008 DIETARYLBL
NUTRIT LBL
HEALTH C