Refusal Actions by FDA as Recorded in OASIS for United Kingdom

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Zetre B.V London , GB BLT-DO 605-2523663-8/16/1 66VBY99 Brylcreem 01-OCT-2008 NOT LISTED DIRECTIONS LACKS N/C LABELING Devdron Ltd Waterford , GB BLT-DO 605-2523663-8/17/1 53LC-06 Astral Moisturizer 01-OCT-2008 CSTIC LBLG COSMETLBLG Magstim Whitland , GB NOL-DO 112-4419489-3/1/1 84N--HI 790571096548 NEVER STIMULATOR 02-OCT-2008 DIRECTIONS NO 510(K) Lipha Pharmaceuticals Ltd West Drayton Middx , GB U87 7QG NOL-DO 112-4547508-5/1/1 61PCB55 855350226030/GLOCOPHAGE 500MG 02-OCT-2008 UNAPPROVED Centura Foods Ltd Droylsden , GB M436DR NWE-DO 144-9549457-9/2/1 21UCI05 SHARWOODS MANGO & GINGER CHUTNEY 06-OCT-2008 NEEDS FCE NO PROCESS Centura Foods Ltd Droylsden , GB M436DR NWE-DO 144-9549457-9/2/2 21UCI05 SHARWOODS MAJOR GREY MANGO CHUTNEY 06-OCT-2008 NEEDS FCE NO PROCESS Centura Foods Ltd Droylsden , GB M436DR NWE-DO 144-9549457-9/2/3 21UCI05 SHARWOODS MAJGREY MANGO CHUTNEY 06-OCT-2008 NEEDS FCE NO PROCESS Centura Foods Ltd Droylsden , GB M436DR NWE-DO 144-9549457-9/2/4 21UCI05 SHARWOODS BENGAL SPICE CHUTNEY 06-OCT-2008 NEEDS FCE NO PROCESS Remedica Publishing London , GB NW13AY NOL-DO 112-4564905-1/3/1 62OCB37 864088047591/HYPERIUM 10-OCT-2008 UNAPPROVED Astrazeneca Uk Limited Macclesfield , GB NOL-DO 600-6315660-2/2/3 66NCB03 Seroquel XR 10-OCT-2008 AGR RX Nasaleze International Limited Douglas, Isle Of Man , GB NYK-DO 739-6146299-8/1/1 66VCY99 NASALEASE COLD & FLU BLOCKER 500MG 100% NATURAL BLOCKER 10-OCT-2008 NOT LISTED UNAPPROVED Nasaleze International Limited Douglas, Isle Of Man , GB NYK-DO 739-6145770-9/1/1 66VBR99 NASAL EASE PUFFER BOTTLE 100% NATURAL ALLERGY BLOCKER 10-OCT-2008 NOT LISTED UNAPPROVED Allen Vanguard Limited Tewkesbury , GB GL20 8TD LOS-DO AEK-9681765-1/1/1 95R--DW XRAY APPARATUS 14-OCT-2008 NO REGISTR Reckitt Benkiser Ltd Swindon , GB SN57XZ LOS-DO AFJ-0040119-5/56/1 66VAU99 ANTIBACTERIAL SOAP 14-OCT-2008 NOT LISTED Sara Lee Household & Body Care Slough FN, GB LOS-DO AFJ-0040119-5/57/1 53JD-01 SLEEP EASY HERBAL BATH 14-OCT-2008 NOT LISTED Wilsons Pharmact London , GB W42BN SAN-DO AEK-6729760-2/1/1 60LAL99 RHODODENDRON BASED MOTHER TINCTURE FOR TREATMENT OF R.A. 20-OCT-2008 NOT LISTED Whitworths Ltd. Orchard Ho Northamptonshire , GB FLA-DO E10-0119346-8/11/1 24AEE51 BIGGA PEAS 20-OCT-2008 NEEDS FCE NO PROCESS H.J.Heinz Company Wigan , GB FLA-DO E10-0119346-8/54/1 38AEE28 MINESTRONE SOUP 20-OCT-2008 NEEDS FCE NO PROCESS A.G. Parfett Ltd Liverpool , GB L103LN FLA-DO E10-0119346-8/121/1 37JCT99 SHARWOOD KORMA 20-OCT-2008 NEEDS FCE NO PROCESS H.R.H. International (North) Billinge,Lanchasire , GB WN5 7BG FLA-DO E10-0119346-8/128/1 37JCE08 TIKKA MASALA SAUCE 20-OCT-2008 NEEDS FCE NO PROCESS John West Foods Ltd. Wigan , GB WN5 0JL FLA-DO E10-0119346-8/129/1 16EYY10 COCKLES IN VINEGAR 20-OCT-2008 NEEDS FCE NO PROCESS John West Foods Ltd. Wigan , GB WN5 0JL FLA-DO E10-0119346-8/130/1 16ECI04 MUSSELS 20-OCT-2008 NEEDS FCE NO PROCESS Nor-Sea Foods Ltd Aberdeen , GB FLA-DO U16-5214371-4/87/1 16SEE73 J. West Mackerel 20-OCT-2008 NEEDS FCE NO PROCESS Hj Heinz Uk Ltd Wugan Lancashire Uk Wn5 , GB FLA-DO U16-5214371-4/72/1 16YCE03 Princes Sardine/Tomato Paste 20-OCT-2008 NEEDS FCE NO PROCESS Nor-Sea Foods Ltd Aberdeen , GB FLA-DO U16-5214371-4/88/1 16CCE12 J. West Cod Roes Soft 20-OCT-2008 NEEDS FCE NO PROCESS Nor-Sea Foods Ltd Aberdeen , GB FLA-DO U16-5214371-4/89/1 16AEE32 J West Salmon Red Wild 20-OCT-2008 NEEDS FCE NO PROCESS Cadbury International Bournville , GB FLA-DO U16-5214371-4/77/1B 34FFT02 Galaxy Minstrels 20-OCT-2008 UNSAFE COL Cadbury International Bournville , GB FLA-DO U16-5214371-4/77/1H 34FFT02 Nestle Aero Peppermint 20-OCT-2008 UNSAFE COL Nor-Sea Foods Ltd Aberdeen , GB FLA-DO U16-5214371-4/90/1 16YEI99 Cockles in Vinegar 20-OCT-2008 NEEDS FCE NO PROCESS Natural Products London , GB LOS-DO 322-5651048-1/5/1 80K--GX BAND-AIDES 21-OCT-2008 NOT LISTED REGISTERED Elemis Ltd Whse & Distribution Somerset , GB FLA-DO MA7-0684688-2/36/1 53LD-99 A & B SLIMMING AMPULES 28-OCT-2008 COSMETLBLG Elemis Ltd Whse & Distribution Somerset , GB FLA-DO MA7-0684688-2/16/1 54YYY99 VITAMINS 28-OCT-2008 NUTRIT LBL Baganovo Barnet , GB EN51RZ LOS-DO AEK-9702947-0/1/1 62ADK05 NON HAZ MEDICATION 31-OCT-2008 UNAPPROVED Baganovo Barnet , GB EN51RZ LOS-DO AEK-9704120-2/1/1 62AIZ05 VIALS OF ZOMETA 31-OCT-2008 NOT LISTED UNAPPROVED