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
Can Mar Grain Products Ltd
Regina SK, CA S4W1B7 NYK-DO 112-1565733-2/1/1
23KGT99 GOLDEN ROASTED FLAX SEED
01-APR-2008 LABELING
NUTRIT LBL
Easy Motion Horse Products Inc.
Grassie CA-ON, CA L0R1M0 NYK-DO BGK-0918386-5/1/1
54YNL99 GUT COAT
01-APR-2008 UNSAFE ADD
Easy Motion Horse Products Inc.
Grassie CA-ON, CA L0R1M0 NYK-DO BGK-0918386-5/3/1
68YDL99 LAST MINUTE TYE
01-APR-2008 UNSAFE ADD
Easy Motion Horse Products Inc.
Grassie CA-ON, CA L0R1M0 NYK-DO BGK-0918386-5/4/1
68YAY99 EQUINE ORGAN SUPPORT
01-APR-2008 NEW VET DR
Easy Motion Horse Products Inc.
Grassie CA-ON, CA L0R1M0 NYK-DO BGK-0918386-5/5/1
68YAY99 EQUINE ORGAN SUPPORT
01-APR-2008 NEW VET DR
Servier Research & Pharmaceutica
Lahore , PK MIN-DO XXX-0153624-3/1/1
61PCC99 Diamicron (Gliclazide) Canadian Prescription Drug
01-APR-2008 UNAPPROVED
Servier Research & Pharmaceutica
Lahore , PK MIN-DO XXX-0153624-3/1/2
61PCC99 Blutab Rosiglitazone
01-APR-2008 UNAPPROVED
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO 551-7355706-2/2/1
53GD-04 FACE PAINT
01-APR-2008 POISONOUS
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO 551-7355706-2/2/2
53GD-04 FACE PAINT - YELLOW
01-APR-2008 POISONOUS
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO 551-7355706-2/2/3
53GD-04 FACE PAINT - ORANGE
01-APR-2008 POISONOUS
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO 551-7355706-2/2/4
53GD-04 FACE PAINT - RED
01-APR-2008 POISONOUS
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO 551-7355706-2/2/5
53GD-04 FACE PAINT - GREEN
01-APR-2008 POISONOUS
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO 551-7355706-2/2/6
53GD-04 FACE PAINT - BLUE
01-APR-2008 POISONOUS
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO 551-7355706-2/2/8
53GD-04 FACE PAINT - BLACK
01-APR-2008 POISONOUS
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO 551-7355706-2/2/7
53GD-04 FACE PAINT - BROWN
01-APR-2008 POISONOUS
Birri & Freres Marche Jean Talon
Montreal CA-QC, CA H2S3A3 NYK-DO 112-1658123-4/7/1
24TGC14 Dandelions
02-APR-2008 PESTICIDE
Moulees Faubert Feeds (1979) Inc.
Huntingdon QC, CA J0S1H0 NYK-DO B04-0015805-9/1/1
70AY-08 BULK MIXED FEED (GRAIN)
02-APR-2008 MFR INSAN
Moulees Faubert Feeds (1979) Inc.
Huntingdon QC, CA J0S1H0 NYK-DO B04-0015805-9/2/1
70MY-01 BULK MIXED FEED
02-APR-2008 MFR INSAN
Les Distilleries Schenley Inc
Salaberry-De-Valleyfield QC, CA J6T2G9 NYK-DO B04-0015805-9/3/1
71FYB02 BULK DISTILLERS
02-APR-2008 MFR INSAN
Moulees Faubert Feeds (1979) Inc.
Huntingdon QC, CA J0S1H0 NYK-DO B04-0015805-9/4/1
70AY-08 BULK MIXED FEED (GRAIN)
02-APR-2008 MFR INSAN
Moulees Faubert Feeds (1979) Inc.
Huntingdon QC, CA J0S1H0 NYK-DO B04-0015805-9/5/1
70AY-02 BULK CORN MEAL
02-APR-2008 MFR INSAN
Pfizer Consumer Gr
Scarborough ON, CA M1L2N3 NOL-DO 112-1981394-9/1/1
56FXK30 792668063052 POLYSPORIN
02-APR-2008 UNAPPROVED
Rocky Mountain Grain Production
Raymondraymond ALBERTA, CA T0K2S0 SEA-DO UPS-0395346-8/1/1
23MGT99 HEMP HEARTS - SHELLED HEMP SEEDS
04-APR-2008 LABELING
NUTRIT LBL
HEALTH C
Body Blue Incorporated
Mississauga ON, CA L5S1B8 NYK-DO 336-4244327-2/1/1
62WBY99 DSE Certain Dri Antiperspirant 1.7 oz
08-APR-2008 NOT LISTED
FALSE
Reena Enterprises Ltd Aka
Scarborough ON, CA M1B3C5 NYK-DO AGW-1234593-8/3/1
09CGT34 ALLMAX CREATINE 400GM
09-APR-2008 MFR INSAN
Sahin International Inc.
Etobicoke ON, CA M9W1P7 NYK-DO 112-1709764-4/5/1
04CGT02 CRISPY NOODLE
10-APR-2008 UNSAFE COL
Leo Pharma Inc
Thornhill NEWFOUNDLAND, CA L3T7W8 DET-DO 112-1583324-8/1/1
61HDO99 Fucidin H Cream
10-APR-2008 UNAPPROVED
Rocky Mountain Grain Production
Raymondraymond ALBERTA, CA T0K2S0 SEA-DO UPS-0487857-3/1/1
26BYT02 HEMP HEARTS - SHELLED HEMP SEEDS
10-APR-2008 LABELING
NUTRIT LBL
HEALTH C
Rocky Mountain Grain Production
Raymondraymond ALBERTA, CA T0K2S0 SEA-DO UPS-0487877-1/1/1
26BYT02 HEMP HEARTS - SHELLED HEMP SEEDS
10-APR-2008 LABELING
NUTRIT LBL
HEALTH C
Rocky Mountain Grain Production
Raymondraymond ALBERTA, CA T0K2S0 SEA-DO UPS-0487909-2/1/1
26BYT02 HEMP HEARTS - SHELLED HEMP SEEDS
10-APR-2008 LABELING
NUTRIT LBL
HEALTH C
A Couple Of Squares
London Ontario, CA N5W4C4 NYK-DO 112-2194281-9/1/1
03JGT99 DECORATED GINGERBREAD COOKIE
14-APR-2008 UNSAFE COL
LIST INGRE
Banner Pharmacaps Canada, Ltd.
Olds Alberta, CA T4H 1S7 SEA-DO 336-5293590-2/1/1
54HCH99 TRE EN EN SOFTGEL CAPSULES
14-APR-2008 UNSAFE COL
LIST INGRE
David Russell
Oshawa ON, CA L1L0A4 DET-DO UPS-0669732-8/1/1
60CCA22 Ephedrine HCL (tablets)
15-APR-2008 DIRECTIONS
INCONSPICU
UNAPPROVED
Johnson & Johnson
Beaconsfield QUEBEC, CA H9W1S7 NOL-DO 112-2119766-1/1/1
65KCK08 864284993860.EYE DROPS
16-APR-2008 UNAPPROVED
A Couple Of Squares
London Ontario, CA N5W4C4 DET-DO UPS-0552863-1/1/1
03JFT99 ICED SUGAR COOKIES
17-APR-2008 UNSAFE COL
COLOR LBLG
Pharmascience Inc.
Montreal QC, CA H4P2T4 NYK-DO 551-7589552-8/1/1
61NQR69 Bulk Gabapentin
17-APR-2008 UNAPPROVED
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/18/1
54HBH04 SYNERGIES OMEGA-KIDS ORANGE CHEWABLE SOFT GELS 60'S (FISH OI
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/17/1
54ABH13 SYNERGIES BERRY-C SYNERGY VITAMIN C 600 MG VEG CAPSULES 90'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/16/1
54YCE99 SYNERGIES PROSTATE-SYNERGY W/ PHYTOSTEROLS SOFT GELS 60'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/15/1
54ABA15 SYNERGIES VITAMIN D SYNERGY 1000 IU TABLETS 180'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/14/1
54YCE99 SYNERGY VEG CAPSULES 60'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/13/1
54HBH04 SYNERGIES OMEGA -SYNERGY FISH OIL CONC SOFT GELS 120'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/12/1
54HBH04 SYNERGIES OMEGA -SYNERGY FISH OIL CONC SOFT GELS 60'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/11/1
54HBH03 SYNERGIES EVENING PRIMROSE OIL 1000 MG W/E SOFT GELS 180'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/10/1
54ACE90 SYNERGIES MULTI-SYNERGY MULTI-VIT & MIN IRON-FREE VEG CAPS 1
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/9/1
54HCH02 SYNERGIES EFA-SYNERGY (BORAGE/FISH/FLAX) 1200 MG SOFT GELS 1
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/8/1
54BCE01 SYNERGIES CAL-MAG CITRATE2:1 W/ ZINC & D CAPSULES 180'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/7/1
54YCE99 SYNERGIES JOINT-SYNERGY DOUBLE-GLUCOSAMINE COMPLEX CAPSULES
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/6/1
54YCE99 SYNERGIES DIGEST - SYNERGY DIGESTIVE ENZYME + BETAINE CAPSUL
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/5/1
54YCE99 SYNERGIES GLS + CHONDROITIN COMPLEX 900 MG CAPSULES 180'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/4/1
54ABH16 SYNERGIES VIT E 400 IU MIXED TOCOPHEROL SOFT GELS 180'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/3/1
54ABE02 SYNERGIES VIT B COMPLEX CAPSULES 100'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/2/1
54ACA90 SYNERGIES MULTI-SYNERGY MULTI VIT TABLETS 100'S
18-APR-2008 MFR INSAN
Accurex Healthcare Mfg Inc
Brantford ON, CA N3R7T4 NYK-DO M76-9300506-9/1/1
54HBH99 SYNERGIES FLAXSEED OIL 1000 MG ORGANIC SOFT GELS 180'S
18-APR-2008 MFR INSAN
Bariatrix Nutrition Inc
Lachine QC, CA H8T1B7 NYK-DO EG6-1491216-0/6/1
23KDN03 SOYA NUTS - BBQ
18-APR-2008 HEALTH C
Canadian Analytical Labs
Scarborough ON, CA M1B3W1 NYK-DO EI5-5113153-1/4/1
46YG-99 CNR SUPPLEMENT
18-APR-2008 INCONSPICU
DIETARY
LACKS N/C
USUAL NAME
FERRERO CANADA INDUSTRIAL DIVISION
Brantford CA-ON, CA N3V1G3 NYK-DO 110-1371365-2/1/1
34FFT99 KINDER SURPRISE CHOCOLATE EGGS
22-APR-2008 IMBED OBJT
Elanco
Guelph ON, CA N1G4T2 DET-DO 112-2162416-9/1/1
56LJF40 858926392663 RUMENSIN (MONENSIN) CAPSULES
22-APR-2008 NEW VET DR
South Shore Seafoods
Bloomfield PRINCE EDWARD ISLAND, CA C0B1E0 NWE-DO 551-6480073-7/1/2
16JGN04 FROZEN DRY PACK LOBSTER MEAT
23-APR-2008 LIST INGRE
LACKS FIRM
Pacific Coast Fruit Products Ltd
Abbotsford Bc, CA V2S7M6 SEA-DO 144-0323154-4/1/1
20DEO05 BLACK CURRANT JUICE CONCENTRATE 65 BRIX
23-APR-2008 PESTICIDES
Pacific Coast Fruit Products Ltd
Abbotsford Bc, CA V2S7M6 SEA-DO 144-0323154-4/1/2
20DEO05 BLACK CURRANT JUICE CONCENTRATE 65 BRIX
23-APR-2008 PESTICIDES
Pacific Coast Fruit Products Ltd
Abbotsford Bc, CA V2S7M6 SEA-DO 144-0323154-4/2/1
20FHO05 BLACK CURRANT PUREE SEEDLESS, PASTEURIZE
23-APR-2008 PESTICIDES
Keung Shing Ginseng And Deer
Windham Centre ONTARIO, CA N0E2A0 SAN-DO DH5-6801098-6/1/1
25NET24 CANADIAN GINSENG ROOT
23-APR-2008 PESTICIDES
L.Davis Textiles (1991) Inc.
Granby CA-QC, CA J2G 9M6 NYK-DO UPS-0667829-4/1/1
89I--ME Natural Hot/Cold Compress
25-APR-2008 NOT LISTED
REGISTERED
Rocky Mountain Grain Production
Raymondraymond ALBERTA, CA T0K2S0 SEA-DO UPS-0672167-2/1/1
26BYT02 HEMP HEARTS - SHELLED HEMP SEEDS
25-APR-2008 LABELING
NUTRIT LBL
HEALTH C
Rocky Mountain Grain Production
Raymondraymond ALBERTA, CA T0K2S0 SEA-DO UPS-0672190-4/1/1
26BYT02 HEMP HEARTS - SHELLED HEMP SEEDS
25-APR-2008 LABELING
NUTRIT LBL
HEALTH C
Sakai Spice Canada Corp.
Lethbridge AB, CA T1H0C8 NYK-DO UPS-0903406-1/1/1
26AHT12 MUSTARD OIL FOR MASSAGE
28-APR-2008 UNSAFE ADD
LACKS FIRM
LACKS N/C
Northern Quinoa Corporation
Kamsack CA-SK, CA S0A 1S0 SEA-DO AD1-0381374-8/1/1
23KGB99 WHOLE FLAXSEED
28-APR-2008 FALSE
LACKS FIRM
LACKS N/C
Pacific Coast Fruit Products Ltd
Abbotsford Bc, CA V2S7M6 SEA-DO 144-0394505-1/1/1
20DEO05 BLACK CURRANT JUICE CONCENTRATE 65 BRIX
28-APR-2008 PESTICIDES
Pacific Coast Fruit Products Ltd
Abbotsford Bc, CA V2S7M6 SEA-DO 144-0394505-1/1/2
20DHO05 BLACK CURRANT JUICE CONCENTRATE 65 BRIX
28-APR-2008 PESTICIDES
Delta Pharma Inc.
Dorval QC, CA H9P1J1 NYK-DO 300-2393850-7/6/1
64XAL03 Blue Rosacea Treatment - Sample
29-APR-2008 NOT LISTED
DIRECTIONS
Delta Pharma Inc.
Dorval QC, CA H9P1J1 NYK-DO 300-2393850-7/10/1
64XAL03 Blue Rosacea Treatment - 1.7oz
29-APR-2008 NOT LISTED
DIRECTIONS
Locher Evers Intl
Vancouver BC, CA V4V2X1 LOS-DO WDN-8250240-3/1/1
16YCE03 PECKS ANCHOVETTE
30-APR-2008 NEEDS FCE
NO PROCESS