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
Brooklyn Bottling Co
Milton, NY 12547 NYK-DO 144-9523457-9/1/1
29BGT99 Rage Asylum Energy Drink (Orange)
03-JUN-2008 DIETARYLBL
NUTRIT LBL
Tahitian Noni International
American Fork, UT 84003-3395 LOS-DO 231-5355426-8/1/1
29AET06 U.S. RETUNED SOY PROTEIN DRINK STRAWBERRY
03-JUN-2008 LIST INGRE
NUTRIT LBL
Kemin Industries Inc
Des Moines, IA 50309-2058 NYK-DO 112-2251776-8/1/1
54BMT15 CHROMIUM ANIMAL FEED SUPPLEMENT
04-JUN-2008 FILTHY
BASF Corporation
Shreveport, LA 71106 NOL-DO 112-6313584-2/1/1A
62GOB86 Allopurinol 300 mg
04-JUN-2008 AGR RX
Pharmacia & Upjohn Company
Kalamazoo, MI 49001 NOL-DO 112-6313584-2/1/1C
64LRP45 Depo-Medrol
04-JUN-2008 AGR RX
Pfizer Animal Health
Exton, PA 19341-2803 NOL-DO 112-6313584-2/1/1B
62GQE88 Rimadyl 75 mg
04-JUN-2008 AGR RX
Spectralytics Inc
Dassel, MN 55325 SAN-DO 112-2656132-5/1/1
74M--AF 864594750493 STENT
04-JUN-2008 NOT LISTED
NO 510(K)
Kao Brands Company
Cincinnati, OH 45214-1729 NYK-DO 231-7678244-2/1/1
53LD-01 BIORE 140G PORE UNCLOGGING SCRUB
04-JUN-2008 LABELING
COSMETLBLG
Ups Oporto
Maiamaia , PT 4470634 NYK-DO UPS-0596225-1/1/1
60LCB85 US GOODS BEING RET'D-MEDICATION(ASACOL 400MG 270TABLETS)
04-JUN-2008 AGR RX
Ups Oporto
Maiamaia , PT 4470634 NYK-DO UPS-0596225-1/1/2
63ACY06 US GOODS BEING RET'D-MEDICATION(EVISTA 60MG 90TABLETS)
04-JUN-2008 AGR RX
Ups Oporto
Maiamaia , PT 4470634 NYK-DO UPS-0596225-1/1/3
61JDY14 US GOODS BEING RET'D-MEDICATION(VYTORIN 10/20MG 90TABLETS)
04-JUN-2008 AGR RX
Ups Oporto
Maiamaia , PT 4470634 NYK-DO UPS-0596225-1/1/4
61MCY06 US GOODS BEING RET'D-MEDICATION(CLONAZEPAM .5MG 90TABLETS)
04-JUN-2008 AGR RX
Ups Oporto
Maiamaia , PT 4470634 NYK-DO UPS-0596225-1/1/5
62TCY02 US GOODS BEING RET'D-MEDICATION(PREVACID 30MG 90TABLETS)
04-JUN-2008 AGR RX
Ups Oporto
Maiamaia , PT 4470634 NYK-DO UPS-0596225-1/1/6
61JCY08 US GOODS BEING RET'D-MEDICATION(CADUET 10/20MG 90TABLETS)
04-JUN-2008 AGR RX
Ups Oporto
Maiamaia , PT 4470634 NYK-DO UPS-0596225-1/1/7
62CCY68 US GOODS BEING RET'D-MEDICATION(BENICAR HCT 40 25MG 90 TABLE
04-JUN-2008 AGR RX
Optical Dynamics Corp
Louisville, KY 40299-2202 CHI-DO MC2-6031309-3/1/1
86H--QG LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION);;
05-JUN-2008 NOT LISTED
REGISTERED
Dell Computer Corp
Round Rock, TX 78682-7000 NYK-DO 112-1917238-7/1/1
94R--BE US GOODS COMPUTER MONITORS
06-JUN-2008 NON STD
Mehron Inc
Chestnut Ridge, NY 10977-7049 NYK-DO M76-6096634-3/10/1
53YH-99 GLITTER DUST (COSTUME MAKEUP)
09-JUN-2008 COSMETLBLG
Mehron Inc
Chestnut Ridge, NY 10977-7049 NYK-DO M76-6096634-3/12/1
53YH-99 METALLIC POWDER, (COSTUME MAKEUP)
09-JUN-2008 COSMETLBLG
Mehron Inc
Chestnut Ridge, NY 10977-7049 NYK-DO M76-6096634-3/14/1
53GD-99 LIQUID MAKE UP (COSTUME MAKEUPS)
09-JUN-2008 COSMETLBLG
Pharmacia Upjohn
Kalamazoo, MI 49001 DET-DO EI5-1775329-5/1/1
77J--XZ 77J--XZ GELFOAM SPONGE DENTAL
10-JUN-2008 NOT LISTED
Dulces Blueberry, S.A. De C.V.
Ciudad Juarez, Chihuahua , MX 32370 SWI-DO 328-3002942-0/5/1
33HGT99 SNAK STOP COCONUT STACKS 12/5.5OZ
10-JUN-2008 NUTRIT LBL
Wedgewood Village Pharmacy Inc.
Swedesboro, NJ 08085-1749 NOL-DO 112-2961350-3/1/1
65PBL02 862425066329/TEI MIX
11-JUN-2008 UNAPPROVED
Brooklyn Bottling Of Milton, NY
Milton, NY 12547-0808 NYK-DO 144-9523410-8/1/1
29BET21 RAGE ASYLUM ENERGY DRINK
16-JUN-2008 UNSAFE COL
LIST INGRE
PRESRV LBL
NUTRIT LBL
Unilever Bestfoods
Harrisburg, PA 17104-2220 NYK-DO 551-6026149-6/1/1
04BHY99 RED COAT NOODLES
16-JUN-2008 SOAKED/WET
Unilever Bestfoods
Harrisburg, PA 17104-2220 NYK-DO 551-6026149-6/2/1
04BHY99 EGG NOODLES, N.E.C.;NONFLEX PLASTIC;NEC
16-JUN-2008 SOAKED/WET
Bristol- Myers Squibb Company
Evansville, IN 47721 CHI-DO 315-6191401-6/1/1
62VCE53 REYATAZ CAP 200MG (AKA ATAZANAVIR)(1BTLX60) IMPORT FOR EXPOR
19-JUN-2008 UNAPPROVED
Bristol- Myers Squibb Company
Evansville, IN 47721 CHI-DO 315-6191398-4/1/1
62VCF49 VIDEX EX CAPSULES 250MG IMPORT FOR EXPORT
19-JUN-2008 UNAPPROVED
Bristol- Myers Squibb Company
Evansville, IN 47721 CHI-DO 315-6191398-4/2/1
62VCF49 VIDEX EX CAPSULES 400MG IMPORT FOR EXPORT
19-JUN-2008 UNAPPROVED
Osteogenics Biomedical Inc.
Lubbock, TX 79424 NOL-DO 112-3154820-0/2/1
76N--QA 942525015961-MEMBRANE MATERIAL
19-JUN-2008 NO PMA
Ultimate Ears Consumer, Llc
Irvine, CA 926183854 CIN-DO UPS-1318224-9/1/1
77E--SD HEARING AID-FOR HEARING USE-DEL TO ULTIMATE EARS LLC IN IRVI
23-JUN-2008 NOT LISTED
REGISTERED
NO 510(K)
Quintiles Clinical Supplies
Mount Laurel, NJ 08054-2227 NOL-DO 112-3146663-5/1/1
66VIP99 858955783942 BIFEPRUNOX RESEARCH KITS
23-JUN-2008 UNAPPROVED
Quintiles Clinical Supplies
Mount Laurel, NJ 08054-2227 NOL-DO 112-3146663-5/2/1
66NIY03 858955783942 QUETIAPINE RESEARCH KITS
23-JUN-2008 UNAPPROVED
Hospira Inc.
Lake Forest, IL 60045-2513 SEA-DO CEB-0001328-8/1/3B
61LCK22 Heparin Solution
23-JUN-2008 AGR RX
Holland America Line -
Seattle, WA 98119-4198 SEA-DO CEB-0001464-1/1/3C
61LCK22 Heparin (Returned for Destruction)
23-JUN-2008 AGR RX
Baldwin Medical Australia
Knoxfield Vic , UA 3180 SAN-DO 336-8735186-9/1/1
79G--EI DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
23-JUN-2008 NOT LISTED
REGISTERED
NO 510(K)
Lyrik Optical
Cincinnati, OH 45209 FLA-DO 112-2892443-0/1/1
86H--QG 855059378863/LENSES
24-JUN-2008 REGISTERED
Medaire, Inc.
Phoenix, AZ 85085-0627 FLA-DO 462-0121215-9/1/1
56BDC03 AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED);
24-JUN-2008 AGR RX
Medaire, Inc.
Phoenix, AZ 85085-0627 FLA-DO 462-0121215-9/1/3
79L--RR KIT, FIRST AID;;
24-JUN-2008 REGISTERED
Medaire, Inc.
Phoenix, AZ 85085-0627 FLA-DO 462-0121215-9/1/5
73K--FZ HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE);;
24-JUN-2008 REGISTERED
NO 510(K)
Medaire, Inc.
Phoenix, AZ 85085-0627 FLA-DO 462-0121215-9/1/6
81J--BF GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING;
24-JUN-2008 REGISTERED
NO 510(K)
Hospira Inc.
Lake Forest, IL 60045-2513 SWI-DO UPS-0043257-0/1/1
60QDK40 1 %LIDOCAINE HCL INJECTION, USP
24-JUN-2008 AGR RX
Everhealth Natural Vitamin Co.
Los Angeles, CA 90013-1631 LOS-DO 004-4962292-7/3/1B
54AYH16 Homeopathic HGH
24-JUN-2008 NOT LISTED
UNAPPROVED
Medaire, Inc.
Phoenix, AZ 85085-0627 FLA-DO 462-0121215-9/1/2
60XCA17 ATENOLOL (ANTI-ADRENERGIC);HUMAN - RX/SINGLE INGREDIENT;PROM
25-JUN-2008 AGR RX
Medaire, Inc.
Phoenix, AZ 85085-0627 FLA-DO 462-0121215-9/1/4
75L--CX KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER;;
25-JUN-2008 REGISTERED
Steiner Transocean Ltd
Middx , GB HA36BZ FLA-DO MA7-0683540-6/6/1
66VBK99 APPER A WHITENING ENHANCER
27-JUN-2008 UNAPPROVED
Lifeline Pharmaceutical
Miami, FL 33126-5535 FLA-DO 112-3160585-1/1/1
78K--OB 857811877610 SUPRAPUBIC CATHETER
27-JUN-2008 REGISTERED
NO 510(K)
Natural Essentials
Streetsboro, OH 44241-5036 NOL-DO 112-1380022-3/1/1
54AYY99 864131708829 DIETARY SUPP.
30-JUN-2008 NO ENGLISH
Nobel Biocare
The Netherlands , NL LOS-DO 336-6588312-3/25/1
76E--IF O-RING RUBBER
30-JUN-2008 NOT LISTED
REGISTERED
Dental Arts Laboratories Inc
Peoria, IL 61603-3625 NOL-DO 112-1382039-5/1/1
76E--GG 857821591293.MAXILLARY
30-JUN-2008 NOT LISTED