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
Paul's Beverages
New Castle, PA 16105-5537 NYK-DO EG6-1465136-2/10/1
29BCT01 CLEARLY CANDIAN STRAWBERRY
01-AUG-2008 NUTRIT LBL
Aim Usa
Nampa, ID 83687-3102 LOS-DO 315-9250252-5/1/1
54FCH99 HERBAL CLEANSING SUPPLEMENT
01-AUG-2008 NOT LISTED
UNAPPROVED
Aim Usa
Nampa, ID 83687-3102 LOS-DO 315-9250252-5/1/2
54FCH99 COMPOSURE SOOTHING HERBAL SUPPLEMENT
01-AUG-2008 NOT LISTED
UNAPPROVED
Bimeda North America
Oakbrook Terrace, IL 601814626 CIN-DO UPS-1704055-9/1/7
64LOK19 DEXAMETHASONE, VET USE
04-AUG-2008 AGR RX
Phoenix Scientific
St . Joseph, MO 64506 CIN-DO UPS-1704055-9/1/8
60LLK71 XYLAZINE, VET USE
04-AUG-2008 AGR RX
Land O Lakes
Carlisle, PA 17013-9270 NYK-DO 112-1871843-8/1/1
09CGT16 MILK SPRAY WHOLE POWDER
04-AUG-2008 POISONOUS
Land O Lakes
Carlisle, PA 17013-9270 NYK-DO 112-1920683-9/1/1
09EGH16 MILK POWDER
04-AUG-2008 BACTERIA
Baxter Health Care
Memphis, TN 38117-2611 CHI-DO 224-0360975-7/1/1
61XPC18 DIPHENHYDRAMINE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
UNAPPROVED
Amphastar Pharmaceuticals, Inc.
S El Monte, CA 91733-3414 CHI-DO 224-0360975-7/1/3
77K--CO ALBUTEROL INHALER FOR AIRLINE MEDICAL KIT FOR INFLIGHT USE
04-AUG-2008 NOT LISTED
Hospira, Inc.
Abbott Park, IL 60064-3503 CHI-DO 224-0360975-7/1/2
60CCP04 EPINEHRINE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
UNAPPROVED
Medique Products
Wood Dale, IL 60191-1204 CHI-DO 224-0360975-7/1/5
60LCP01 ACETAMINOPHEN FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Medique Products
Wood Dale, IL 60191-1204 CHI-DO 224-0360975-7/1/6
61XCP18 DIPHENHYDRAMINE FOR UAL MEDICAL KIT FOR INFLIGHT USE
04-AUG-2008 NOT LISTED
UNAPPROVED
KV Pharmaceutical Co
Earth City, MO 63045-1403 CHI-DO 224-0360975-7/1/7
66SCA28 NOTROSTAT TAB FOR AIRLINE MEDICAL KIT FOR INFLIGHT USE
04-AUG-2008 NOT LISTED
UNAPPROVED
Amphastar Pharmaceuticals, Inc.
S El Monte, CA 91733-3414 CHI-DO 224-0360975-7/1/8
61KCP05 ATROPINE SULFATE FOR ARILINE MEDICAL KIT ONLY
04-AUG-2008 NOT LISTED
UNAPPROVED
Hospira, Inc.
Abbott Park, IL 60064-3503 CHI-DO 224-0360975-7/1/9
61LCP20 DEXTROSE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Hospira, Inc.
Abbott Park, IL 60064-3503 CHI-DO 224-0360975-7/1/10
60CCP04 EPINEHRINE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
UNAPPROVED
Hospira, Inc.
Abbott Park, IL 60064-3503 CHI-DO 224-0360975-7/1/11
60QCP07 LIDOCAINE FOR UAL MEDICAL KITS FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
UNAPPROVED
Central Admixture Pharmacy Inc.
Bethlehem, PA 18018-3524 CHI-DO 224-0360975-7/1/12
80F--OZ IV CATHETER FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
NO 510(K)
ICU Medical (Utah) Inc.
Salt Lake City, UT 84123-2504 CHI-DO 224-0360975-7/1/13
80L--HI IV SET FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Hospira, Inc.
Abbott Park, IL 60064-3503 CHI-DO 224-0360975-7/1/14
55RG-55 SODIUM CHLORIDE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Dynarex Corporation
Orangeburg, NY 10962 CHI-DO 224-0360975-7/1/15
73C--AO AIRWAYS FOR AIRLINE MEDICAL KITS FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Ambu Incorporated
Glen Burnie, MD 21060 CHI-DO 224-0360975-7/1/16
73K--GB AMBU BAG/MASK FOR AIRLINE MEDICAL KIT INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Medline Industries, Inc
Dallas, TX 75237 CHI-DO 224-0360975-7/1/17
80L--KB ALCOHOL WIPES FOR MEDICAL KITS FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Medline Industries, Inc
Dallas, TX 75237 CHI-DO 224-0360975-7/1/18
80L--ZC NITRILE GLOVES FOR UAL MEDICL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
NO 510(K)
Armstrong Medical Industries Inc.
Lincolnshire, IL 60069-3616 CHI-DO 224-0360975-7/1/19
80J--OK SCISSORS FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Medline Industries, Inc
Dallas, TX 75237 CHI-DO 224-0360975-7/1/20
80K--GX TAPE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Medline Industries, Inc
Dallas, TX 75237 CHI-DO 224-0360975-7/1/21
79G--AX TOURNIQUET FOR UAL MEDICAL KIT FOR IN FLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Mabis Healthcare Inc
Park City, IL 60085-6715 CHI-DO 224-0360975-7/1/22
74D--XQ BLOOD PRESSURE CUFF FOR UAL MEDICAL KIT FOR INFLIGHT USE
04-AUG-2008 NOT LISTED
UNAPPROVED
Mabis Healthcare Inc
Park City, IL 60085-6715 CHI-DO 224-0360975-7/1/23
74L--DE STETHOSCOPE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Coviden Lp
Mansfield, MA 02048-1113 CHI-DO 224-0360975-7/1/24
80F--MI NEEDLES FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
04-AUG-2008 NOT LISTED
Amgen Inc
Thousand Oaks, CA 91320-1799 NYK-DO EI5-5118464-7/1/1
60LCK99 ENBREL 25 (etanercept)
04-AUG-2008 NOT LISTED
Liberty Welding & Iron Works Co
Metairie, LA 70001-5450 FLA-DO M05-0334433-1/10/1
73C--BF CHAMBER, HYPERBARIC;;
04-AUG-2008 REGISTERED
NO 510(K)
Aseptic Solutions
Coronacorona, CA 92880 LOS-DO 336-8066101-7/1/1
20DCF99 HIMALAYAN GOJI JUICE
04-AUG-2008 NEEDS FCE
NO PROCESS
Barmensen Inc
Denver, CO 80239-2338 NYK-DO UPS-1058158-3/1/1A
54FYJ99 2.0 oz tube of MAXODERM
06-AUG-2008 UNAPPROVED
Barmensen Inc
Denver, CO 80239-2338 NYK-DO UPS-1058158-3/1/1B
54FYJ99 .2 oz packetes of Maxoderm
06-AUG-2008 UNAPPROVED
Barmensen Inc
Denver, CO 80239-2338 NYK-DO UPS-1058158-3/1/1D
54FCA99 15 Vazomyne Tablets.
06-AUG-2008 UNAPPROVED
McNeil PPC Inc.
Morris Plains, NJ 07950-2523 NYK-DO DP4-0438191-6/1/1
62MAJ08 BENGAY PATCHS
06-AUG-2008 NOT LISTED
Colgate Palmolive Co
New York, NY 10022 NYK-DO DP4-0443664-5/1/1
63RAJ04 TOOTHPASTE
06-AUG-2008 NOT LISTED
Topix Pharmaceuticals Inc.
Amityville, NY 11701 NYK-DO GU6-9941792-4/1/1
66PCY99 FDX807 Oil Free Non-Paba Moisturizing Sun Screen SPF30
07-AUG-2008 NOT LISTED
Unilever Bestfoods
Harrisburg, PA 17104-2220 NYK-DO 551-6029930-6/1/1
04ACT99 OTHER PASTA
11-AUG-2008 FOREIGN OB
Unilever
Harrisburg, PA 17104-2220 NYK-DO 551-6007023-6/1/1
04YDN02 STRING HOPPERS RED NOODLES
11-AUG-2008 FILTHY
Eli Lilly
INDIANAPOLIS, IN 46221-2004 DET-DO 336-8835721-2/1/1
61LIA99 PRASUGREL TABLET
11-AUG-2008 LACKS FIRM
INCONSPICU
Tahitian Noni International Inc
Provo, UT 84604-5787 SWI-DO 231-5356794-8/1/1
41YHY99 Dietary Supplement Capsules
11-AUG-2008 DIETARYLBL
Stewart Medical
Abbotsford BC, CA V2T6H8 SEA-DO UPS-2058750-5/1/1
80K--MI HEWLETT PACKARD VIRIDIA PATIENT MONITORING SYSTEM
13-AUG-2008 NOT LISTED
NO 510(K)
Tootsie Roll Industries, Inc.
Chicago, IL 60629-5818 NYK-DO UPS-1615562-2/3/1
33UHT02 Gum Ball Dispenser
21-AUG-2008 UNSAFE COL
LIST INGRE
LACKS N/C
NUTRIT LBL
Universal Marine Med Supplies
Brooklyn, NY 11219-4513 NOL-DO 112-1453988-7/1/1
61RCY01 859009110737 DIMERCAPROL
21-AUG-2008 INSANITARY
UNAPPROVED
Hvl Inc.
Pittsburgh, PA 15205-9742 NOL-DO 112-1491206-8/1/1
54YCY99 799272835407 CREADEX SUPPLEMENT
21-AUG-2008 HEALTH C
Spellman High Voltage
Hauppauge, NY 11788-3951 NOL-DO 112-1437576-1/1/1
90I--YB 949224503593 X-RAY TUBE
22-AUG-2008 NON STD
Merck & Co., Inc.
Whitehouse Station, NJ 08889-3400 NOL-DO 112-1415225-1/1/1
64UAA06 857257634798/PROPECIA 1MG
22-AUG-2008 AGR RX
Bilcare Inc
Phoenixville, PA 19460 NOL-DO 112-1575953-4/1/1
56IDA76 838133605822 AZITHROMYCIN 250MG
22-AUG-2008 AGR RX
Shering Plough
San Juan, NY 09326 NOL-DO 112-1696147-7/1/1
56OCA02 852587005316/AVELOX 400MG TABLETS
22-AUG-2008 UNAPPROVED
Shering Plough
San Juan, NY 09326 NOL-DO 112-1696147-7/1/2
61XCA99 852587005316/CLARINEX 2.5MG TABLETS
22-AUG-2008 UNAPPROVED
Fujisawa Healthcare Inc
Deerfield, IL 60015-2537 NYK-DO M76-8510336-9/1/1
64TCJ08 PROTOPIC (Tacrolimus) 0.1% Ointment
22-AUG-2008 AGR RX
Williams Healthcare Systems, Inc.
Elgin, IL 60123-5215 DET-DO 988-0105804-5/1/1
89J--FB Chiropractic Table
25-AUG-2008 NOT LISTED
REGISTERED
Bristol-Myers
Princeton, NJ 08543-4500 FLA-DO 112-4007728-2/1/1
66VIP99 865811143081/GLUCOVANCE 1.25MG
25-AUG-2008 UNAPPROVED
John Hullot
Las Vegas, NV 89102 FLA-DO 112-3998888-7/1/1
76E--LW 865847841620 IMPRESSION MATERIAL
25-AUG-2008 REGISTERED
Taylor
Winter Park, FL 32789-4318 FLA-DO 112-3999837-3/1/1
77K--CO 855303584745 INHALER
25-AUG-2008 REGISTERED
Taylor
Winter Park, FL 32789-4318 FLA-DO 112-3999837-3/1/2
80L--DQ 855303584745 INHALER DEVICE
25-AUG-2008 REGISTERED
Lund Eye Care Associates
Salida, CO 81201-2018 FLA-DO 112-3937127-4/1/1
86N--JH 846250208125 EYEGLASSE
25-AUG-2008 REGISTERED
NO 510(K)
Taylor
Winter Park, FL 32789-4318 FLA-DO 112-3999837-3/2/1
77E--PN 855303584745 NEBULIZER
26-AUG-2008 REGISTERED
Mannkind Corporation
Danbury, CT 06810-6903 PHI-DO SG5-0418613-4/1/1
66VIY99 TECHNOSPHERCOMPLETED THE STUDY AND ARE RETURNING DRUG TO BE
26-AUG-2008 UNAPPROVED
Mannkind Corporation
Danbury, CT 06810-6903 PHI-DO SG5-0418613-4/1/2
66VIY99 TECHNOSPHERCOMPLETED THE STUDY AND ARE RETURNING DRUG TO BE
26-AUG-2008 UNAPPROVED
Mannkind Corporation
Danbury, CT 06810-6903 PHI-DO SG5-0418614-2/1/1
66VIY99 TECHNOSPHERCOMPLETED THE STUDY AND ARE RETURNING DRUG TO BE
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418180-4/1/1
66VIY99 VYTORIN 10 MG & 40 MG
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418180-4/1/2
66VIY99 SIMVASTATIN
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418180-4/2/1
55YP-99 VYTORIN PLACEBO
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418180-4/2/2
55YP-99 SIMVASTATIN PLACEBO
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418492-3/1/1
66VIY99 VYTORIN 10 MG
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418492-3/1/2
66VIY99 SIMVASTATIN
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418492-3/1/3
66VIY99 VYTORIN 40MG
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418492-3/2/1
55YP-99 VYTORIN PLACEBO
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418492-3/2/2
55YP-99 SIMVASTATIN PLACEBO
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418924-5/1/1
66VIY99 VYTORIN 10 MG & 40 MG IND# 65066 RETURNED BECAUSE DRUG EXP
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418924-5/1/2
66VIY99 SIMVASTATIN IND#65066 RETURNED BECAUSE DRUG EXPIRED
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418924-5/2/1
55YP-99 VYTORTIN PLACEBO IND#65066 RETURNED BECAUSE DRUGS EXPIRED
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418924-5/2/2
55YP-99 SIMVASTATIN PLACEBO IND#65066 RETURNED BECAUSE DRUGS EXPIRED
26-AUG-2008 UNAPPROVED
Merck Sharp & Dohm
Northumberlan , GB PHI-DO SG5-0418926-0/2/1
55YP-99 VYTORTIN PLACEBO, EXPIRED, RETURNED
26-AUG-2008 UNAPPROVED
Merck Sharp & Dohm
Northumberlan , GB PHI-DO SG5-0418972-4/2/1
55YP-99 VYTORTIN PLACEBO, USED, RETURNED
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418974-0/1/1
66VIY99 VYTORIN 10 MG & 40 MG, USED & EXPIRED, SPOSNOR MSP
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418974-0/2/1
55YP-99 VYTORTIN PLACEBO
26-AUG-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0418974-0/2/2
55YP-99 SIMVASTATIN PLACEBO
26-AUG-2008 UNAPPROVED
Abbott Laboratories
North Chicago, IL 60064-1803 PHI-DO 231-1219030-4/1/1
56YIP99 ORITAVACIN 20 CC VIAL
26-AUG-2008 UNAPPROVED
Via Cell Inc
Cambridge, MA 02142-1200 NYK-DO 112-3194843-4/1/1
81M--YK 860793969480 CORD BLOOD COLLECTION KITS
27-AUG-2008 NOT LISTED
NO 510(K)
El Dorado Royal A Spa Resort
Playa Del Carmenplaya Del Carmen , MX 77710 CIN-DO UPS-2027623-2/1/1
64GDA19 KARIVA 28, GENERIC FOR MIRCETTE, RX, US GOODS RETURNING
29-AUG-2008 AGR RX
Toshiba Logistics America, Inc.
Wayne, NJ 07470-3114 FLA-DO TW2-0012816-7/1/1
94V--07 COLOR TV SETS / FOR EXPORT ONLY / EXPORT ONLY
29-AUG-2008 NON STD