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
Hewlett Packard
Palo Alto Ca, CA 94303 FLA-DO 112-4550485-0/1/1
95L--30 862285620150 LASER PRINTER
01-OCT-2008 NO REGISTR
Speciosa Specialist
Chicago, IL 60642-5449 CIN-DO UPS-2337261-6/1/1
66VCL99 ERR: CBP#06 /KRATOM ALKALOID INCENSE: MITRAGYNA SPECIOSA / F
02-OCT-2008 DIRECTIONS
Speciosa Specialist
Chicago, IL 60642-5449 CIN-DO UPS-2337285-5/1/1
66VCL99 KRATOM ALKALOID INCENSE/USED FOR INCENSE FOR RELAXATION/2 BO
02-OCT-2008 DIRECTIONS
Adventis Pharma
Lexington, KY 40511-8627 NOL-DO 112-4489410-4/3/1
54YEC99 861486000353 DININTEL
02-OCT-2008 UNAPPROVED
Francisco Morales
Mexico Dfmexico Df , MX 62589 CIN-DO UPS-2393227-8/1/1
63NDC25 URSODIOL, RX, US GOODS RETURNING
03-OCT-2008 AGR RX
Francisco Morales
Mexico Dfmexico Df , MX 62589 CIN-DO UPS-2393227-8/1/2
63EDC13 PROPRANOLOL, RX, US GOODS RETURNING
03-OCT-2008 AGR RX
Eastern Fisheries, Inc.
New Bedford, MA 02740-7348 NYK-DO 112-3973083-4/1/1
16EGD05 FROZEN SCALLOPS
07-OCT-2008 FILTHY
LACKS N/C
Mbm Trading
Brampton ONTARIO, CA L6S6G2 NYK-DO 144-1330994-2/1/1
53JI-02 Ultra Clear Degree Anti-Perspirant/Deoderant (Men)
08-OCT-2008 NOT LISTED
INCONSPICU
LABELING
Mbm Trading
Brampton ONTARIO, CA L6S6G2 NYK-DO 144-1330994-2/2/1
53JY-01 Soap
08-OCT-2008 LABELING
COSMETLBLG
Deltatrak Technologies
Santee, CA 92071-5616 SAN-DO 112-4230087-2/1/1
80F--LL 865121068496 DIGITAL THERMOMETERS
09-OCT-2008 REGISTERED
NO 510(K)
Onsite Dental
San Carlos, CA 94070 NOL-DO 112-4588793-3/1/1
76K--LC 861877138985/DENTAL CHAIR
10-OCT-2008 NOT LISTED
Onsite Dental
San Carlos, CA 94070 NOL-DO 112-4588793-3/1/2
76K--LC 861877138985/DENTAL STOOL
10-OCT-2008 NOT LISTED
Onsite Dental
San Carlos, CA 94070 NOL-DO 112-4588793-3/1/3
76E--BA 861877138985.DENTAL LIGHT
10-OCT-2008 NOT LISTED
Onsite Dental
San Carlos, CA 94070 NOL-DO 112-4588793-3/1/4
90M--UH 861877138985/DENTAL XRAY
10-OCT-2008 NOT LISTED
FAILS STD
NO 510(K)
Creaciones Anysa Sl
Elda , ES CIN-DO AEK-9978583-0/1/1
78G--CP ENDOSCOPES-AGR
10-OCT-2008 NOT LISTED
Creaciones Anysa Sl
Elda , ES CIN-DO AEK-9978583-0/1/2
78G--CP ENDOSCOPES-AGR
10-OCT-2008 NOT LISTED
Bristol-Meyers Squibb
Princeton, NJ 08543-4000 NOL-DO 600-6315660-2/2/1
66NCA06 Abilify Discmelt 10 mg
10-OCT-2008 AGR RX
Bristol-Meyers Squibb
Princeton, NJ 08543-4000 NOL-DO 600-6315660-2/2/2
66NCA06 Abilify Discmelt 15mg
10-OCT-2008 AGR RX
National Precision
Oakford, PA 19053-7310 CIN-DO UPS-2410166-7/1/3
79F--ZT CUTTER-FOR DENTAL USE-DEL TO MASEL IND IN BRISTOL, PA
14-OCT-2008 NOT LISTED
Biomet, Inc.
Warsaw, IN 46582 FLA-DO K51-0065292-1/1/1
87K--WK FIXTATION DEVICE(FOR EXPORT ONLY).
14-OCT-2008 REGISTERED
Biomet, Inc.
Warsaw, IN 46582 FLA-DO K51-0065292-1/1/2
87H--WC VARIOUS SCREWS(FOR EXPORT ONLY).
14-OCT-2008 REGISTERED
Forest Pharmaceuticals Inc
Earth City, MO 63045 CIN-DO UPS-2496917-0/1/1
61NIY83 LEXAPRO, ESCITALOPRAM OXALATE, GOING TO BE DESTROYED,RTS# 1R
16-OCT-2008 AGR RX
Pfizer Inc.
New York, NY 10017 CIN-DO UPS-2496917-0/1/2
66VCA99 LYRICA, PREGABALIN, GOING TO BE DESTROYED,RTS# 1R12V17HRL8
16-OCT-2008 AGR RX
Arnet Pharmaceutical Corp.
Davie, FL 33317 NYK-DO M76-9326416-1/1/1
54FCH99 EM / A-PLEX
17-OCT-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
Celmark International
W Caldwell, NJ 07006 NYK-DO M76-9326416-1/2/1
54FCH99 GI DTOX
17-OCT-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
Arnet Pharmaceutical Corp.
Davie, FL 33317 NYK-DO M76-9326416-1/3/1
54FCH99 HM DTOX
17-OCT-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
Arnet Pharmaceutical Corp.
Davie, FL 33317 NYK-DO M76-9326416-1/4/1
54FCH99 L DTOX
17-OCT-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
Celmark International
W Caldwell, NJ 07006 NYK-DO M76-9326416-1/5/1
54FCH99 TFN-PLEX
17-OCT-2008 DIETARYLBL
NUTRIT LBL
HEALTH C
Alexandria Hospital
Nevis Vi, VI FLA-DO 201-1959178-1/1/1
73C--BK 740 VENTILATOR SKB-MIA
20-OCT-2008 REGISTERED
Ziyad Brothers Importing
Cicero, IL 60804-4431 NYK-DO 300-2872927-3/1/1
29BET99 VIMTO CARBONATED FRUIT DRINK
23-OCT-2008 LIST INGRE
PRESRV LBL
Advanced Microderm
Schaumburgschaumburg, IL 60193 LOS-DO MA7-0684818-5/2/1
79G--FE MICRODERMABRASION MACHINE FOR USE IN THE SPA
27-OCT-2008 REGISTERED
Ups Tsg
Lachine QC, CA H8T3H2 CIN-DO UPS-2644508-8/1/1
61PDK17 LANTUS SOLOSTAR, ISULIN INJ. DEVICE, RX, US GOODS RETURN
30-OCT-2008 AGRINSULIN
Ups Tsg
Lachine QC, CA H8T3H2 CIN-DO UPS-2644508-8/1/2
61PDK17 HUMALOG PEN, INSULIN INJECT. DEVICE, RX, US GOODS RETURN
30-OCT-2008 AGRINSULIN
The Winning Combination Usa Inc
Long Beach, CA 908142273 NYK-DO UPS-1472218-9/1/1
66YAY99 Resolve The Natural Stop Smoking Aid (Wild Cherry)
30-OCT-2008 UNAPPROVED
Avlon Industries, Inc
Melrose Park, IL 60160-1402 FLA-DO AV3-0020484-7/1/4B
61HBY05 K.C. Dry & bItchy Scalp Moisturizing Conditioner
31-OCT-2008 DRUG NAME
UNAPPROVED
Avlon Industries, Inc
Melrose Park, IL 60160-1402 FLA-DO AV3-0020484-7/1/5B
64XBY06 K.C.Dry & itchy Scalp Glossifier
31-OCT-2008 DRUG NAME
UNAPPROVED
Neogen Corporation
Lansing, MI 48912 LOS-DO AEK-9697144-1/1/1
88L--DT VERATOX FUMONISIN
31-OCT-2008 NO 510(K)
Neogen Corporation
Lansing, MI 48912 LOS-DO AEK-9697144-1/1/2
88L--DT VERATOX AFLATOXIN
31-OCT-2008 NO 510(K)
Neogen Corporation
Lansing, MI 48912 LOS-DO AEK-9697144-1/1/3
88L--DT AFLATOXIN HS VERATOX
31-OCT-2008 NO 510(K)
Neogen Corporation
Lansing, MI 48912 LOS-DO AEK-9697144-1/1/4
88L--DT VERATOX ZEARALENONE
31-OCT-2008 NO 510(K)
Neogen Corporation
Lansing, MI 48912 LOS-DO AEK-9697144-1/1/5
88L--DT VERATOX DON
31-OCT-2008 NO 510(K)
Neogen Corporation
Lansing, MI 48912 LOS-DO AEK-9697144-1/1/6
88L--DT FILTER SYRINGES
31-OCT-2008 NO 510(K)