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
Mars International Travel
Veghel , NL NYK-DO P64-0020795-7/15/1
34CFT02 CHOCOLATES
01-MAY-2008 UNSAFE COL
LIST INGRE
LACKS N/C
NUTRIT LBL
Mars International Travel
Veghel , NL NYK-DO P64-0020795-7/17/1
34CFT02 CHOCOLATES
01-MAY-2008 UNSAFE COL
LIST INGRE
LACKS N/C
NUTRIT LBL
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0417561-6/1/1
66VIY99 VYTORIN OR PLACEBO RETURN FOR DESTRUCTION
02-MAY-2008 UNAPPROVED
Schering Corporation
Lafayette, NJ 07848-4613 PHI-DO SG5-0417561-6/1/2
66VIY99 SIMVASTATIN OR PLACEBO RETURN FOR DESTRUCTION
02-MAY-2008 UNAPPROVED
Biomet
Parsippany, NJ 07054-1149 LOS-DO AEK-7741534-3/1/1
87M--QP MEDICAL GEO CAGES-SPINAL CAGES/SPACERS
02-MAY-2008 NOT LISTED
REGISTERED
Protein Research
Livermore, CA 94551-7635 SAN-DO AN1-0320574-4/1/1
54YCH99 FERTILITY BLEND FOR MEN
06-MAY-2008 NO ENGLISH
American Lifestyle
Pittsford, NY 14534 PHI-DO UPS-0382235-8/1/1
64RBE99 SEX SUPPLEMENT CAPSULES -NATURA-VIGA PN#080077389486
08-MAY-2008 UNAPPROVED
Ben Venue Laboratories Inc
Bedford, OH 44146-4650 PHI-DO SG5-0417044-3/1/1
66VIY99 XL119 DEAE REBECCAMYCIN
09-MAY-2008 UNAPPROVED
Duramed Pharmaceuticals Inc
Pomona, NY 10970-2931 DET-DO 112-2377404-6/1/1
64GCY29 859016983302 LEVONORGESTREL PLAN B CONTRACEPTIVE
09-MAY-2008 NOT LISTED
UNAPPROVED
Victor Packing Inc
Madera, CA 93637-9108 SAN-DO BNU-0005222-8/2/1
23BFH12 AGR,WALNUT HALVES RTN INSECTS
Partial Refusal 12-MAY-2008 FILTHY
Spectraytics
Dassel, MN 55325 SAN-DO 112-2561302-8/1/1
74N--IQ 864594750596 STENT
13-MAY-2008 NOT LISTED
NO 510(K)
Diamond Raisins
Ivanhoe, CA 93235-1056 DET-DO BGK-0323138-9/42/1
20BGT10 RAISINS
14-MAY-2008 LIST INGRE
NUTRIT LBL
Ocular Instruments Inc
Bellevue, WA 98004-3015 SAN-DO 112-2385366-7/1/1
86H--NR 863936739251 OPTHALMIC FORCEPS
15-MAY-2008 NOT LISTED
Xlear Inc.
Orem, UT 84057-4407 NYK-DO D03-0162236-7/24/1A
33UGT99 SPRY SUGAR FREE CHEWING GUM (FRESH FRUIT)
16-MAY-2008 LACKS N/C
Xlear Inc.
Orem, UT 84057-4407 NYK-DO D03-0162236-7/24/1B
33UGT99 SPRY SUGAR FREE CHEWING GUM (PEPPERMINT)
16-MAY-2008 LACKS N/C
Xlear Inc.
Orem, UT 84057-4407 NYK-DO D03-0162236-7/24/1C
33UGT99 SPRY SUGAR FREE CHEWING GUM (CINNAMON)
16-MAY-2008 LACKS N/C
Xlear Inc.
Orem, UT 84057-4407 NYK-DO D03-0162236-7/24/1D
63RAJ99 SPRY TOOTHPASTE
16-MAY-2008 NOT LISTED
Xlear Inc.
Orem, UT 84057-4407 NYK-DO D03-0162236-7/24/1E
63RAJ99 SPRY TOOTH GEL
16-MAY-2008 NOT LISTED
Intercos Italia S.P.A
Milano , IT LOS-DO MH7-4011421-9/1/1A
53LC-03 STILA SUN SPF 15 SHADE 02-INTERNATIONAL
19-MAY-2008 NOT LISTED
Intercos Italia S.P.A
Milano , IT LOS-DO MH7-4011421-9/1/1B
53LC-03 IPF REFEIT SPF 12-WATTS
19-MAY-2008 NOT LISTED
Baxter Health Care
Memphis, TN 38117-2611 CHI-DO 224-0360913-8/1/1
61XPC18 DIPHENHYDRAMINE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
UNAPPROVED
Hospira, Inc.
Abbott Park, IL 60064-3503 CHI-DO 224-0360913-8/1/2
60CCP04 EPINEHRINE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
UNAPPROVED
Amphastar Pharmaceuticals, Inc.
S El Monte, CA 91733-3414 CHI-DO 224-0360913-8/1/3
77K--CO ALBUTEROL INHALER FOR AIRLINE MEDICAL KIT FOR INFLIGHT USE
23-MAY-2008 NOT LISTED
DE/RX KIT
UNAPPROVED
Medique Products
Wood Dale, IL 60191-1204 CHI-DO 224-0360913-8/1/4
60LCP05 ASPIRIN FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
UNAPPROVED
Medique Products
Wood Dale, IL 60191-1204 CHI-DO 224-0360913-8/1/5
60LCP01 ACETAMINOPHEN FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
UNAPPROVED
Medique Products
Wood Dale, IL 60191-1204 CHI-DO 224-0360913-8/1/6
61XCP18 DIPHENHYDRAMINE FOR UAL MEDICAL KIT FOR INFLIGHT USE
23-MAY-2008 NOT LISTED
DE/RX KIT
UNAPPROVED
KV Pharmaceutical Co
Earth City, MO 63045-1403 CHI-DO 224-0360913-8/1/7
66SCA28 NOTROSTAT TAB FOR AIRLINE MEDICAL KIT FOR INFLIGHT USE
23-MAY-2008 NOT LISTED
DE/RX KIT
UNAPPROVED
Amphastar Pharmaceuticals, Inc.
S El Monte, CA 91733-3414 CHI-DO 224-0360913-8/1/8
61KCP05 ATROPINE SULFATE FOR ARILINE MEDICAL KIT ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
UNAPPROVED
Hospira, Inc.
Abbott Park, IL 60064-3503 CHI-DO 224-0360913-8/1/9
61LCP20 DEXTROSE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
UNAPPROVED
Hospira, Inc.
Abbott Park, IL 60064-3503 CHI-DO 224-0360913-8/1/10
60CCP04 EPINEHRINE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
UNAPPROVED
Hospira, Inc.
Abbott Park, IL 60064-3503 CHI-DO 224-0360913-8/1/11
60QCP07 LIDOCAINE FOR UAL MEDICAL KITS FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
UNAPPROVED
Central Admixture Pharmacy Inc.
Bethlehem, PA 18018-3524 CHI-DO 224-0360913-8/1/12
80F--OZ IV CATHETER FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
NO 510(K)
ICU Medical (Utah) Inc.
Salt Lake City, UT 84123-2504 CHI-DO 224-0360913-8/1/13
80L--HI IV SET FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
NO 510(K)
Hospira, Inc.
Abbott Park, IL 60064-3503 CHI-DO 224-0360913-8/1/14
55RG-55 SODIUM CHLORIDE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
UNAPPROVED
Dynarex Corporation
Orangeburg, NY 10962-1207 CHI-DO 224-0360913-8/1/15
73C--AO AIRWAYS FOR AIRLINE MEDICAL KITS FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
NO 510(K)
Medline Industries, Inc
Dallas, TX 75237 CHI-DO 224-0360913-8/1/18
80L--ZC NITRILE GLOVES FOR UAL MEDICL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
NO 510(K)
Armstrong Medical Industries Inc.
Lincolnshire, IL 60069-3616 CHI-DO 224-0360913-8/1/19
80J--OK SCISSORS FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
Medline Industries, Inc
Dallas, TX 75237 CHI-DO 224-0360913-8/1/21
79G--AX TOURNIQUET FOR UAL MEDICAL KIT FOR IN FLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
Mabis Healthcare Inc
Park City, IL 60085-6715 CHI-DO 224-0360913-8/1/22
74D--XQ BLOOD PRESSURE CUFF FOR UAL MEDICAL KIT FOR INFLIGHT USE
23-MAY-2008 NOT LISTED
DE/RX KIT
NO 510(K)
Mabis Healthcare Inc
Park City, IL 60085-6715 CHI-DO 224-0360913-8/1/23
74L--DE STETHOSCOPE FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
NO 510(K)
Coviden Lp
Mansfield, MA 02048-1113 CHI-DO 224-0360913-8/1/24
80F--MI NEEDLES FOR UAL MEDICAL KIT FOR INFLIGHT USE ONLY
23-MAY-2008 NOT LISTED
DE/RX KIT
NO 510(K)
Medrad Inc
Warrendale, PA 15086 FLA-DO DM9-8010501-7/1/1
74I--ZQ CONTRAST DELIVERY INJECTOR FOR EXPORT ONLY
23-MAY-2008 REGISTERED
NO 510(K)
Mylan Pharmaceuticals Inc
Morgantown, WV 26505-3276 NOL-DO 112-0044942-2/1/1
65QCY60 862480988424 CYCLOBENZA PRINE
27-MAY-2008 AGR RX
Ranbaxy Pharmaceuticals, Inc.
Princeton, NJ 08540-6636 NOL-DO 112-0424587-5/5/1
56YCB99 AMPICILLIN
27-MAY-2008 UNAPPROVED
Proctor & Gamble
Ross, OH 45061 NOL-DO 112-0424587-5/2/1
61HAL17 860755876569 CHLOROSEPTIC
28-MAY-2008 UNAPPROVED
Airborne Health
Carmel, CA 93921 NOL-DO 112-0424587-5/3/1
54AYY99 860755876569 VITAMIN SUPP.
28-MAY-2008 DIETARYLBL
Ivax Pharmaceuticals Ireland
Waterford , IE 1234 NYK-DO AEK-9102088-9/1/1
63BDZ25 ADVAIC DISKUS
30-MAY-2008 NOT LISTED
UNAPPROVED