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
La Petite Bretonne Inc
Blainville QC, CA J7C2N5 NYK-DO 551-6494451-9/1/2
03RGT01 Tea Cakes
01-AUG-2007 LIST INGRE
Produits Achtaroute Inc
Montreal QC, CA H4N2R5 NWE-DO 112-6786478-5/1/6
03AGT09 ZAATA - THYME (Pita)
01-AUG-2007 LIST INGRE
LACKS N/C
USUAL NAME
TRANSFAT
NUTRIT LBL
Produits Achtaroute Inc
Montreal QC, CA H4N2R5 NWE-DO 112-6786478-5/2/1
03RGT64 BAKLAVA
01-AUG-2007 LIST INGRE
LACKS N/C
TRANSFAT
Produits Achtaroute Inc
Montreal QC, CA H4N2R5 NWE-DO 112-6786478-5/2/4
03RGT64 BAKLAVA
01-AUG-2007 LIST INGRE
LACKS N/C
TRANSFAT
Produits Achtaroute Inc
Montreal QC, CA H4N2R5 NWE-DO 112-6786478-5/3/1
03RGT99 COCONUT COOKIE
01-AUG-2007 LIST INGRE
LACKS N/C
Convergent Media Network
Vancouver BC, CA V6Z2R6 NOL-DO 112-6303245-2/1/1
61JIY14 861539790222 SIMVASTATIN TABLETS
01-AUG-2007 UNAPPROVED
Sam's Delights
St Catharines CA-ON, CA L2R6P7 DET-DO 906-0030236-9/1/2
23GVT02 Mixed Nuts- 6 lb
Partial Refusal 02-AUG-2007 INCONSPICU
Cynovad Inc.
Saint-Laurent Quebec, CA H4S 1V9 NYK-DO M76-3667684-4/1/1
76L--YB NEO SCAN OPTICAL SCANNER
03-AUG-2007 NOT LISTED
NON STD
NO 510(K)
Encore Gourmet Food Corp
Senneville QC, CA H9X4B4 DET-DO EG6-8931411-0/6/1
28BHH08 CHILI POWDER
06-AUG-2007 SALMONELLA
Encore Gourmet Food Corp
Senneville QC, CA H9X4B4 DET-DO EG6-8931411-0/7/1
28JHT99 CHICKEN & MEAT SEASONING
06-AUG-2007 SALMONELLA
Encore Gourmet Food Corp
Senneville QC, CA H9X4B4 DET-DO EG6-8931411-0/11/1
28KHT99 GARLIC PEPPER
06-AUG-2007 SALMONELLA
Encore Gourmet Food Corp
Senneville QC, CA H9X4B4 DET-DO EG6-8931411-0/14/1
28EHT01 ITALIAN SEASONING
06-AUG-2007 SALMONELLA
Encore Gourmet Food Corp
Senneville QC, CA H9X4B4 DET-DO EG6-8931411-0/15/1
28FHH99 LEMON PEPPER
06-AUG-2007 SALMONELLA
Tai Foong International Ltd
Scarborough ON, CA M1X1E6 NYK-DO H67-1298053-0/1/1
16AGD15 FROZEN EEL
07-AUG-2007 VETDRUGRES
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO 551-6982374-2/2/1B
53GD-09 Orange Face Paint
08-AUG-2007 COSM COLOR
CONTAINER
Advitech Inc
Quebec QC, CA G2K2C9 DET-DO 112-7576472-0/1/1
62NBA99 856370937321 DERMATOLIGICAL DERMYLEX
08-AUG-2007 DIRECTIONS
PERSONALRX
UNAPPROVED
Basse And Freres
Montreal QC, CA H4N1M2 NYK-DO 110-7617866-6/15/1
23KGT01 PUMPKINS SEEDS
09-AUG-2007 UNSAFE COL
THE CANADA GINSENG TECHNOLOGY
North York CA-ON, CA M3N1H5 DET-DO 112-7138967-0/1/1
54EBY12 FRESH GINSENG, CULTIVATED
10-AUG-2007 PESTICIDES
THE CANADA GINSENG TECHNOLOGY
North York CA-ON, CA M3N1H5 DET-DO 112-7138967-0/1/2
54EBY12 FRESH GINSENG, CULTIVATED
10-AUG-2007 PESTICIDES
Ferring Inc.
Torontotoronto ONTARIO, CA M2J5C1 CIN-DO 110-9100997-1/1/1
64MCK05 MENOTROPINS VIALS FOR INJECTIONS, RX, FOR CIT, PER USE
15-AUG-2007 DRUG GMPS
UNAPPROVED
Tap Pharmaceutical Prod
Lake Forest, IL 60045-4832 CIN-DO 110-9100997-1/1/2
62ICK86 LEUPROLIDE ACETATE FOR INJECTIONS, RX, FOR CIT PER USE
15-AUG-2007 DRUG GMPS
UNAPPROVED
Krista Castellarin
Sherwood Park AB, CA T8A6P1 CIN-DO 110-9100997-1/1/3
64MCK04 GONADOTROPHINE CHORIONIQUE FOR INJECTION, RX, FOR CIT PER US
15-AUG-2007 DRUG GMPS
UNAPPROVED
Krista Castellarin
Sherwood Park AB, CA T8A6P1 CIN-DO 110-9100997-1/1/4
64MCK07 GONAL FOLLITROPIN PEN FOR INJECTION, RX, FOR CIT PER USE
15-AUG-2007 DRUG GMPS
UNAPPROVED
Sanda Pastries Inc
Brossard Quebec, CA J4Y2P4 NYK-DO 551-7056176-0/1/18
03NFD01 Orange Mango Cake
15-AUG-2007 COLOR LBLG
Ramico Foods Inc
Saint-Leonard QC, CA H1P2A2 NYK-DO EG6-1355390-8/31/1
02YEE99 CLIC COUSCOUS BOUILLON WITH VEGTABLES
15-AUG-2007 LIST INGRE
LACKS N/C
NUTRIT LBL
NO PROCESS
Ramico Foods Inc
Saint-Leonard QC, CA H1P2A2 NYK-DO EG6-1355390-8/32/1
02YEE99 CLIC COUSCOUS BOUILLON WITH CICKEN AND VEGETABLES
15-AUG-2007 LACKS N/C
NUTRIT LBL
NO PROCESS
Ramico Foods Inc
Saint-Leonard QC, CA H1P2A2 NYK-DO EG6-1355390-8/33/1
02YEE99 CLIC COUSCOUS BOUILLON WITH LAMB AND VEGETABLES
15-AUG-2007 LACKS N/C
NUTRIT LBL
NO PROCESS
Ramico Foods Inc
Saint-Leonard QC, CA H1P2A2 NYK-DO EG6-1355390-8/34/1
02YEE99 CLIC COUSCOUS BOUILLON WITH BEEF AND VEGETABLES
15-AUG-2007 LACKS N/C
NUTRIT LBL
NO PROCESS
Ramico Foods Inc
Saint-Leonard QC, CA H1P2A2 NYK-DO EG6-1355390-8/35/1
02YEE99 CLIC COUSCOUS BOUILLON WITH HARISSAAND VEGETABLES
15-AUG-2007 LACKS N/C
NUTRIT LBL
NO PROCESS
Eli Lilly Canada Inc.
Toronto ON, CA DET-DO 110-9370625-1/1/1
63ACA06 RALOXIFENE-CBP DRUG SEIZURE SHIPMENT
15-AUG-2007 DIRECTIONS
PERSONALRX
UNAPPROVED
Patheon Ym
North York ON, CA M3B1Y5 NOL-DO 112-7499217-3/2/1
61GCJ06 861499451171 NEO MYCIN
15-AUG-2007 UNAPPROVED
Living Synergy Inc
Sidney BRITISH COLUMBIA, CA V8L5R8 NOL-DO 112-7586149-2/1/1
54ABA90 856006241031 SUPPLEMENTS
15-AUG-2007 NUTRIT LBL
Oakrun Farm Bakery Limited
Ancaster ON, CA L9G3L3 DET-DO 112-6914230-5/1/5
03RHN35 Prem Rasp Danish Ring 8 X 1
20-AUG-2007 UNSAFE COL
COLOR LBLG
Oakrun Farm Bakery Limited
Ancaster ON, CA L9G3L3 DET-DO 112-7442099-3/1/10
03RHN35 US SUPREME RASP RING DAN 8X1
20-AUG-2007 UNSAFE COL
LIST INGRE
Isagenix
Calgarycalgary ALBERTA, CA T2C4Y7 SEA-DO 110-9107674-9/1/1
54YCF04 VARIOUS DIETARY SUPPLEMENTS
20-AUG-2007 SBGINSENG
Woolwich Dairy Inc
Orangeville Ontario, CA L9W4Z4 NYK-DO 551-5281667-9/1/15
12CGP12 GOAT CHEESE - MC BRUSCHETTA RND
20-AUG-2007 LIST INGRE
LACKS N/C
Kaire
Langleylangley BRITISH COLUMBIA, CA V3A8C4 CIN-DO 110-9277633-9/1/1B
54YCY99 AGRUMAX Supplement
21-AUG-2007 UNAPPROVED
Odem International Inc
Rosemere QC, CA J7A3A7 SEA-DO 110-8021611-4/1/1
36CET04 RAW CAN WHITE HONEY/ODEM
21-AUG-2007 FILTHY
POISONOUS
Perfection Foods (1991)
Charlottetown CA-PE, CA C1A1S6 NWE-DO 310-9306963-6/1/1
09CEE03 MILK, SWEETENED/CONDENSED (09CEE03)
23-AUG-2007 NO PROCESS
Health Trek
Selkirk MB, CA R1A0T3 MIN-DO XXX-0151738-3/1/1
54ECY99 Friendly Digest - Herbal Supplement
23-AUG-2007 DIETARYLBL
LACKS FIRM
NUTRIT LBL
Health Trek
Selkirk MB, CA R1A0T3 MIN-DO XXX-0151738-3/1/3
54ECY99 Heavenly Orchard Herbal Concentrate (Dietary Supplement)
23-AUG-2007 DIETARYLBL
LACKS FIRM
NUTRIT LBL
Health Trek
Selkirk MB, CA R1A0T3 MIN-DO XXX-0151738-3/1/2
54ECY99 Kelp PLUS (Dietary Supplement)
23-AUG-2007 DIETARYLBL
LACKS FIRM
NUTRIT LBL
Paladin Labs Inc
Montreal QC, CA H4P2T4 NOL-DO 112-7662394-1/1/1
78M--RE 846047485208 CYSTISTAT
24-AUG-2007 NO PMA
Apotex Inc
North York ON, CA M9L1T9 NOL-DO 112-7802197-9/1/1
61MCB41 859020455518 DIVALPROEX 125 MG
27-AUG-2007 UNAPPROVED
Nanogen
Etobicoke ONTARIO, CA M9C1C2 NOL-DO 112-7782795-4/1/1
75M--MI 735304409462/TNI-MYO TEST
27-AUG-2007 NOT LISTED
REGISTERED
NO 510(K)
Signature Bakery Inc
North York ON, CA M3J2J2 NYK-DO 186-6015341-4/2/1
03TGT50 CINNAMON ROLLS - B/F
28-AUG-2007 LIST INGRE
Signature Bakery Inc
North York ON, CA M3J2J2 NYK-DO 186-6015341-4/4/1
03RGT40 MINI BUTTER TARTS - ASST GOURMET
28-AUG-2007 LIST INGRE
NUTRIT LBL
Dawn Foods Canada
Etobicoke CA-ON, CA M9B6B6 NYK-DO 310-1111231-1/1/1
21GGT03 GLACE CHERRY HALVES
28-AUG-2007 UNSAFE COL
LIST INGRE
PRESRV LBL
LACKS N/C
English Bay Batter (Toronto Inc)
Mississauga ON, CA L5T2G8 NYK-DO 144-0773652-2/1/1
14BFF99 ORIGINAL NON DAIRY VEGETABLE-BASED BEVERAGE
28-AUG-2007 LIST INGRE
LACKS N/C
NEEDS FCE
NO PROCESS
Apavet Bioceutical
Edmonton ALBERTA, CA T5M0T1 NOL-DO 112-7263222-7/1/1
68GDY20 855004628600 Relaxen, Kinesa, Respire, Resiste, and Rejuven
28-AUG-2007 NO ENGLISH
Larrearx Strategies Inc
Richmond BC, CA V6V2E4 SEA-DO 144-0145688-7/1/1
66VBE99 LarreaRx - Larrea tridentata extract capsules
28-AUG-2007 UNAPPROVED
McNeil Consumer Healthcare
Guelph ON, CA N1K1A5 NOL-DO 112-7312885-2/1/1
60LDB01 791341608904 TYLENOL 500MG
29-AUG-2007 UNAPPROVED
McNeil Consumer Healthcare
Guelph ON, CA N1K1A5 NOL-DO 112-7312885-2/1/2
60LDB01 791341608904 Truly
29-AUG-2007 UNAPPROVED
LILYDALE CO-OP, WYNYARD RENDERING DIVISION
WYNYARD CA-SK, CA S0A 4T0 SEA-DO AZJ-0056795-7/1/1
71BYB99 POULTRY MEAL
30-AUG-2007 SALMONELLA
LILYDALE CO-OP, WYNYARD RENDERING DIVISION
WYNYARD CA-SK, CA S0A 4T0 SEA-DO AZJ-0056843-5/1/1
71LYB99 POULTRY MEAL
30-AUG-2007 SALMONELLA
Acts
Dorval QUEBEC, CA H4Y1G1 NOL-DO 112-7428807-7/1/1
79L--RR 858925823590 FIRST AID KIR
31-AUG-2007 NOT LISTED
NO 510(K)