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
Astra Zeneca
Wilmington, DE 19810 NOL-DO 112-0099448-4/1/1
62TCB06 918019441407 NEXIUM
06-MAR-2008 AGR RX
Natural Health Technologies Co
Gardena, CA 90249-2202 LOS-DO GJ8-0049079-0/1/1
41YGT99 Omnizyme
06-MAR-2008 LIST INGRE
DIETARY
NO ENGLISH
Majestic Aerotech Inc.
Eatontown, NJ 07724-2212 NOL-DO 112-0130628-2/1/1
79L--RR 798802455905FIRST AID KIT
06-MAR-2008 NOT LISTED
NO 510(K)
P S International Ltd
Chapel Hill, NC 27517-8834 SWI-DO H87-0155305-4/1/1
12AGO05 CHEDDAR CHEESE FINES
10-MAR-2008 FILTHY
Advantech Ltd
Fort Dodge, IA 50501-6723 NYK-DO 144-1390773-7/1/1
54AMY90 15CC VITAMIN B ANIMAL ADDITIVE
11-MAR-2008 FALSE
Alkermes Inc
Cambridge, MA 02139-4137 NOL-DO 112-1657227-4/1/1
60MIY28 861166531312 VIVITROL
13-MAR-2008 UNAPPROVED
Red Gold Inc.
Geneva, IN 46740-1061 NYK-DO EG6-1437432-0/1/1
37KYY99 Tomato Paste / Tomato Sauce
14-MAR-2008 LACKS N/C
NUTRIT LBL
Miller Brewing Co.
Milwaukee, WI 532082866 LOS-DO 620-5910594-0/2/1
32AEP04 BAD BEER BEING RETURNED FOR DESTRUCTION
17-MAR-2008 MFR INSAN
Miller Brewing Co.
Milwaukee, WI 532082866 LOS-DO 620-5910594-0/2/2
32AEP04 BAD BEER BEING RETURNED FOR DESTRUCTION
17-MAR-2008 MFR INSAN
Creation Garden Natural Product
Valencia, CA 91355-3468 LOS-DO 336-8047144-1/1/1
54ACA16 Breast Gain Plus
18-MAR-2008 NOT LISTED
UNAPPROVED
C & H NATURAL KIM, CORP.
Glendale, CA 91203-2824 LOS-DO M42-1567377-1/1/1
54FCZ12 VITA SLP POWDER
20-MAR-2008 LIST INGRE
Wakunaga Of America Co Ltd
Mission Viejo, CA 92691-2744 LOS-DO 065-1244092-3/1/1
54FBT10 KYOLIC RED YEAST RICA (DIETARY SUPPLEMENT)
20-MAR-2008 UNSFDIETSP
Kmax Health Products Co
Pomona, CA 91766 LOS-DO W69-4058699-4/2/1A
54YCH99 MULTIVITAMINS AND MINERALS
20-MAR-2008 UNSAFE COL
LIST INGRE
DIETARYLBL
MFR INSAN
NO ENGLISH
Kmax Health Products Co
Pomona, CA 91766 LOS-DO W69-4058699-4/2/1B
54YCH99 MULTIVITAMINS AND MINERALS
20-MAR-2008 UNSAFE COL
LIST INGRE
DIETARYLBL
MFR INSAN
NO ENGLISH
Hi-Tech Pharmaceutical
Norcross, GA 30071-3575 CIN-DO UPS-0311319-6/1/1
60NCA03 HI-TECH PHARM DIANABOL DIET SUPPLEMENTS
21-MAR-2008 UNAPPROVED
Wheaton Brace Company
Carol Stream, IL 60188 NYK-DO 310-1308357-7/1/1
80F--RP HARNESS FOR CHILD
21-MAR-2008 NOT LISTED
REGISTERED
NO 510(K)
Bristol-Myers Squibb Company
Garden City, NY 11530-3333 NOL-DO 112-1791247-9/1/1
61LDP38 943030052729 PLAVIX 75MG
24-MAR-2008 UNAPPROVED
Braun Medical
Allentown, PA 18109-9515 NYK-DO UPS-0427400-5/1/1
80L--JS SAFETY IV CATHETERS
26-MAR-2008 NO 510(K)
Pharmacia & Upjohn
Mississauga ON, CA H9J2M5 DET-DO UPS-0194022-8/1/1
77K--HJ GELFOAM (K060878)
28-MAR-2008 NOT LISTED
Pharmacia & Upjohn
Mississauga ON, CA H9J2M5 DET-DO UPS-0194517-7/1/1
77K--HJ GELFOAM (K060878)
28-MAR-2008 NOT LISTED
Inamed Asthetics
Santa Barbara, CA 93111-2919 NOL-DO 112-1722117-8/2/1
80L--DQ 862425085791 MEDICAL DEVICE ELASTENCE
28-MAR-2008 NO PMA
Dairy Farmers of America Inc
Cabool, MO 65689-9334 NYK-DO NY2-0207542-8/1/1
09CEE11 ENFAGROW VANILLA RTD X 16'S 237ML LOT AAN03
28-MAR-2008 LACKS N/C
NUTRIT LBL
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/19
61NCC73 MIRTAZAPINE (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/18
60LCC85 CANASA (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/17
61NCC32 IMIPRAMINE (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/16
64UCC03 CARBIDOPA
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/15
65QCC65 TIZANIDINE (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/14
65QCC31 CHLORZOXAZONE (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/13
64XCC07 TRETINOIN CREAM (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/12
62LCB40 METRONIDAZOLE (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/11
56ECC60 MINOCYCLINE (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/10
62VCB18 ACYCLOVIR (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/9
61WCC45 FLUCONAZOLE (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/8
61NCB67 FLUVOXAMINE (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/7
64BCC24 FUROSEMIDE (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/6
63ECB13 PROPRANOLOL (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/5
65ACB04 NAMENDA (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/4
66TCC01 ALLOPURINOL (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/3
64GCC13 ESTRADIOL (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/2
64UCB01 STALEVO (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/2/1
62OCB48 NICARDIPINE (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX
Global Rx Inc
Efland, NC 27243-9624 LOS-DO AEK-7749384-5/1/1
56BCY03 AMOXICILLIN (FORMAL ENTRY REQURIED BY FDA)
28-MAR-2008 AGR RX