Refusal Actions by FDA as Recorded in OASIS for United States
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Calva Internacional.S.A. De C.V.
Tijuana, Baja Californi , MX 22014 SWI-DO AVR-0015792-4/1/1A
69CB-43 Calf formula
04-DEC-2007 DIRECTIONS
LIST INGRE
NO ENGLISH
Calva Internacional.S.A. De C.V.
Tijuana, Baja Californi , MX 22014 SWI-DO AVR-0015792-4/1/1B
69CB-43 Calf formula
04-DEC-2007 DIRECTIONS
LIST INGRE
NO ENGLISH
Gerber Scientific Instruments Co
Tolland, CT 06084-2806 MIN-DO 110-0981026-4/1/1
95R--FZ BAR CODE READER (HAND HELD)
04-DEC-2007 NON STD
NO REGISTR
Cyberwize.Com, Inc.
Sarasota, FL 34232-6244 SEA-DO 110-0966600-5/1/1A
54YCL04 TUNGUSKA BLAST DIETARY SUPPLEMENT
05-DEC-2007 SBGINSENG
D Alessio
Victoria BC, CA V8Z7C2 SEA-DO 110-1014518-9/1/1
80L--DQ MEDICAL DEVICE
07-DEC-2007 NOT LISTED
Borderlink Veterinary Supplies Inc
Barrie ONTARIO, CA L4N0W5 NYK-DO 144-0797984-1/1/1
54FML99 HOMEOPATHIC LIQUID FOR ANIMALS
10-DEC-2007 INCONSPICU
Borderlink Veterinary Supplies Inc
Barrie ONTARIO, CA L4N0W5 NYK-DO 144-0797984-1/1/2
54FMJ99 HAND CREAM ANIMALS
10-DEC-2007 INCONSPICU
Borderlink Veterinary Supplies Inc
Barrie ONTARIO, CA L4N0W5 NYK-DO 144-0797984-1/1/3
54FML99 ANXIETY AROMA THERAPY
10-DEC-2007 INCONSPICU
Pilling-Weck Lp
Markham ON, CA L3R3K7 NOL-DO 112-0268212-9/1/1
77K--CG 799223526461 ESOPHAGUS DILATOR
10-DEC-2007 NOT LISTED
Takeda Pharmaceuticals North America, Inc.
Lincolnshire, IL 60069-2934 NOL-DO 112-0330394-9/3/1
61PCB63 864089185400/ACTOS
10-DEC-2007 AGR RX
Serola Biomechanics
Loves Park, IL 61111-2727 NOL-DO 112-0312215-8/1/1
87H--SQ 950999123790/ BELTS
11-DEC-2007 NOT LISTED
Serola Biomechanics
Loves Park, IL 61111-2727 NOL-DO 112-0312215-8/2/1
89I--QI 950999123790 / BRACES
11-DEC-2007 NOT LISTED
Serola Biomechanics
Loves Park, IL 61111-2727 NOL-DO 112-0312215-8/3/1
77M--YB 950999123790 / PILLOW
11-DEC-2007 NOT LISTED
Mavidonmedical Products
Lake Worth, FL 33461-4202 NOL-DO 112-0433791-2/1/1
89I--MD 792605285654 HOT COLD PACK
11-DEC-2007 NOT LISTED
Mavidonmedical Products
Lake Worth, FL 33461-4202 NOL-DO 112-0433939-7/1/1
89I--MD 798817878884 HOT/COLD PACK
11-DEC-2007 NOT LISTED
Mavidonmedical Products
Lake Worth, FL 33461-4202 NOL-DO 112-0434760-6/3/1
89I--MD 791443167386 HOT COLD PACK
11-DEC-2007 NOT LISTED
Mavidonmedical Products
Lake Worth, FL 33461-4202 NOL-DO 112-0433715-1/1/1
89I--MD 792462032370 HOT COLD PACK
11-DEC-2007 NOT LISTED
Mavidonmedical Products
Lake Worth, FL 33461-4202 NOL-DO 112-0433389-5/3/1
89I--LO 799229080577/HEAT/COLD PACK
12-DEC-2007 NOT LISTED
Catalent
St Petersburg, FL 33716-1016 NYK-DO 802-0021177-1/1/1
62UAH11 ROBITUSSIN COUGHGELS(END USER:WYETH)
12-DEC-2007 FALSE
Catalent
St Petersburg, FL 33716-1016 NYK-DO 802-0022276-0/1/1
62UAH11 ROBITUSSIN COUGH GELS (END USER:WYETH) OTC
12-DEC-2007 NOT LISTED
FALSE
Bayer Healthcare, LLC
Morristown, NJ 07960-4526 NYK-DO 112-0548801-1/1/1
64GCY29 861870019673 MIRENA INTRAUTERINE SYSTEM
12-DEC-2007 UNAPPROVED
Mavidonmedical Products
Lake Worth, FL 33461-4202 NOL-DO 112-0433490-1/3/1
89I--MD 791806410315 HOT COLD PACK
12-DEC-2007 NOT LISTED
Mavidonmedical Products
Lake Worth, FL 33461-4202 NOL-DO 112-0394257-1/1/1
89I--MD 791804662521 HOT/COLD PACKS
12-DEC-2007 NOT LISTED
Mavidonmedical Products
Lake Worth, FL 33461-4202 NOL-DO 112-0394582-2/1/1
89I--MD 790388606638 HOT/COLD PACKS
12-DEC-2007 NOT LISTED
Mavidonmedical Products
Lake Worth, FL 33461-4202 NOL-DO 112-0394457-7/1/1
89I--MD 799227119567 H0OT/COLD PACK
12-DEC-2007 NOT LISTED
Mavidonmedical Products
Lake Worth, FL 33461-4202 NOL-DO 112-0394639-0/1/1
89I--MD 791804360830 HOT/COLD GEL PACKS
12-DEC-2007 NOT LISTED
Mavidonmedical Products
Lake Worth, FL 33461-4202 NOL-DO 112-0394674-7/1/1
89I--MD 791440509455 HOT/COLD PACKS
12-DEC-2007 NOT LISTED
Aai International
Wilmington, NC 28405-1815 NOL-DO 112-0407538-9/1/1
61XCB45 858928945553/CETIRIZINE HCL
12-DEC-2007 UNAPPROVED
Companhia Petroquimica Do Sul
Triunfobrazil , BR 95853 FLA-DO DD2-2701721-5/1/1
73B--ZD PERSONAL RESPIRATOR
13-DEC-2007 REGISTERED
NO 510(K)
Tuscany Eyewear
Davie, FL 33325 NOL-DO 112-0497835-0/1/1
86H--QZ 861877654698 FRAMES
13-DEC-2007 NOT LISTED
Volano Therapeutics Inc
Rancho Cordova, CA 95670 SAN-DO 112-0111344-9/1/1
78M--SD 859954941850 CATHETER
14-DEC-2007 NOT LISTED
NO 510(K)
Biomerieux Inc
Hazelwood, MO 63042-2320 NOL-DO 112-0607361-4/1/1
75J--LW 858927457671/REAGEMT ASSSAY TSH KITS
14-DEC-2007 NOT LISTED
NO 510(K)
Abbott Diagnostics
Abbott Park, IL 60064 NOL-DO 112-0607361-4/3/1
75J--JI 858927457671/REAGENT ASSAY PSA KITS
14-DEC-2007 NOT LISTED
NO 510(K)
Abbott Diagnostics
Abbott Park, IL 60064 NOL-DO 112-0607361-4/4/1
75C--DX 858927457671/REAGENT ASSAYS TSH KITS
14-DEC-2007 NOT LISTED
NO 510(K)
Abbott Diagnostics
Abbott Park, IL 60064 NOL-DO 112-0607361-4/5/1
75C--EC 858927457671/REAGENT ASSAYS KITS
14-DEC-2007 NOT LISTED
NO 510(K)
Sigma-Tau Pharmaceuticals Inc
Gaithersburg, MD 20878-7352 NOL-DO 112-0496449-1/1/1
65CDK07 864333991150 CARNITOR
14-DEC-2007 UNAPPROVED
E. Fougera & Company
Melville, NY 11747-3838 NOL-DO 112-0496449-1/1/5
64LDK03 864333991150 BETAMETHASONE 60ML
14-DEC-2007 UNAPPROVED
Boehringer Ingelheim Pharmaceuticals, Inc.
Danbury, CT 06810-5103 NOL-DO 112-0496449-1/1/6
63BDK26 864333991150 ATROVENT INHALER
14-DEC-2007 UNAPPROVED
Steiner Transocean Ltd
Middx , GB HA36BZ FLA-DO MA7-0683579-4/1/1
76E--EG APPER A WHITENING ENHANCER
17-DEC-2007 NOT LISTED
REGISTERED
Schering Plough Animal Health Corporation
Summit, NJ 07901-1330 NOL-DO 112-0506668-4/1/1B
56DXO21 853037141153.OTOMAX
18-DEC-2007 PERSONALRX
Coastal Contacts
Vancouver BRITISH COLUMBIA, CA V5M3M4 SEA-DO 110-0806371-7/1/1
86L--PL CONTACT LENSES - FRESHLOOK COLORS
20-DEC-2007 NOT LISTED
NO 510(K)
Td Research
Mckinney, TX 75070 NOL-DO 112-0569477-4/1/1
54ADB99 861871116754 Jobelyn Herbal Nutritional Supplement
20-DEC-2007 HEALTH C
Gamay Flavors
Alexandria, VA 22304 CIN-DO 110-1352287-1/1/1
54YCK99 MALEENHANCEMENTSUPPLEMENT/GAMAYALEXANDRIAVA/COMMERCIAL
21-DEC-2007 INCONSPICU
Breeders Choice Pet Foods Inc
Irwindale, CA 91706-2084 LOS-DO E37-0029559-4/11/1
72BFB05 BEEFY STIX TREATS
26-DEC-2007 FILTHY
Breeders Choice Pet Foods Inc
Irwindale, CA 91706-2084 LOS-DO E37-0029559-4/10/1
72AFB05 Avoderm Natural Booster Pet Cat Food
26-DEC-2007 FILTHY
Breeders Choice Pet Foods Inc
Irwindale, CA 91706-2084 LOS-DO E37-0029559-4/9/1
72BFB05 Active Care Biscuits Pet Dog Food
26-DEC-2007 FILTHY
Breeders Choice Pet Foods Inc
Irwindale, CA 91706-2084 LOS-DO E37-0029559-4/8/1
72AFB05 Select Choice Feline Lite Pet Cat Food
26-DEC-2007 FILTHY
Breeders Choice Pet Foods Inc
Irwindale, CA 91706-2084 LOS-DO E37-0029559-4/7/1
72BFB05 Active Care Chicken & Rice Pet Dog Food
26-DEC-2007 FILTHY
Breeders Choice Pet Foods Inc
Irwindale, CA 91706-2084 LOS-DO E37-0029559-4/6/1
72AFB05 Avoderm Natural Kitten & Adult (200BG) + Select Choice Origi
26-DEC-2007 FILTHY
Breeders Choice Pet Foods Inc
Irwindale, CA 91706-2084 LOS-DO E37-0029559-4/5/1
72AFB05 Avoderm Natural Kitten & Adult (15CS) + Avoderm Natural Hair
26-DEC-2007 FILTHY
Breeders Choice Pet Foods Inc
Irwindale, CA 91706-2084 LOS-DO E37-0029559-4/4/1
72BFB05 Avoderm Natural Lite (30BG) + Active Care Chicken & Rice (88
26-DEC-2007 FILTHY
Breeders Choice Pet Foods Inc
Irwindale, CA 91706-2084 LOS-DO E37-0029559-4/3/1
72BFB05 Natural Chicken & Rice (120BG) + Natural Lamb & Rice (210bg)
26-DEC-2007 FILTHY
Breeders Choice Pet Foods Inc
Irwindale, CA 91706-2084 LOS-DO E37-0029559-4/2/1
72BFB05 Avoderm Natural Chicken & Rice (30BG) + Avoderm Natural Lamb
26-DEC-2007 FILTHY
Breeders Choice Pet Foods Inc
Irwindale, CA 91706-2084 LOS-DO E37-0029559-4/1/1
72BFB05 Avoderm Natural Chicken & Rice (12CS) +Avoderm Natural Lite
26-DEC-2007 FILTHY
Foot Levelers Inc
Roanoke, VA 24027-2611 NYK-DO 110-0923662-7/1/1
80L--DQ POSTUREMETER
27-DEC-2007 NOT LISTED
Volano Therapeutics Inc
Rancho Cordova, CA 95670 SAN-DO 112-8490713-8/1/1
74D--YG 859954941816 CARDIOVASCULAR CATHETER
27-DEC-2007 NOT LISTED
REGISTERED
NO 510(K)
Novartis Inst For Biomed Researc
East Hanover, NJ 07936-1016 NOL-DO 112-0708251-5/1/1
62ODB14 860621667682 / AMLIBON
27-DEC-2007 UNAPPROVED
First Horizon
Alpharetta, GA 30005-8350 NOL-DO 112-0708251-5/1/2
61PDB26 860621667682 / METFORMIN
27-DEC-2007 UNAPPROVED
Medical Packaging Corporation
Camarillo, CA 93012-8755 NOL-DO 112-0707771-3/1/1
88N--JT 861497264520 / CHLYMADIA KIT
27-DEC-2007 NOT LISTED