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
Janssen - Cilag Farmaceutica, Lda Queluz De Baixo , PT 2745555 CIN-DO 110-1142640-6/1/1 68YYY99 CLOSANTEL MEBENDAZOLE ORAL SUSPENSION, VETERINARY PRODUCTS 02-JAN-2008 NEW VET DR Alston Garrard &Co Kingsbridge , GB TQ71GB NYK-DO 101-7623295-6/2/1 63HAL99 LAXATIVE 02-JAN-2008 NOT LISTED UNAPPROVED Birds Eye Limited LONDON , GB LOS-DO 946-0604372-0/3/1 16CFT12 4 Cod Cakes In crunch crumb 03-JAN-2008 LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Nisa Today's (Holdings) Ltd., DN15 8RG , GB LOS-DO 946-0604372-0/15/1 16IMN21 Scottish Boned KIPPER FILLETS with butter 03-JAN-2008 LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Buxton Spa Bakeries Ltd. Buxton GB-DBY, GB SK179JL LOS-DO 946-0604372-0/25/1 03RFT40 6 Mince Pies 03-JAN-2008 UNSAFE COL COLOR LBLG LACKS N/C NUTRIT LBL Buxton Spa Bakeries Ltd. Buxton GB-DBY, GB SK179JL LOS-DO 946-0604372-0/27/1 03RGT35 6 Bakewell Tarts 03-JAN-2008 LACKS N/C NUTRIT LBL Buxton Spa Bakeries Ltd. Buxton GB-DBY, GB SK179JL LOS-DO 946-0604372-0/29/1 03RGT35 6 Lemon Bakewell Tarts 03-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL Buxton Spa Bakeries Ltd. Buxton GB-DBY, GB SK179JL LOS-DO 946-0604372-0/30/1 03RGT35 6 Blackcurrant Bakewell Tarts 03-JAN-2008 LACKS N/C NUTRIT LBL Buxton Spa Bakeries Ltd. Buxton GB-DBY, GB SK179JL LOS-DO 946-0604372-0/31/1 03RGT35 6 Strawberry Bakewell Tarts 03-JAN-2008 LACKS N/C NUTRIT LBL Buxton Spa Bakeries Ltd. Buxton GB-DBY, GB SK179JL LOS-DO 946-0604372-0/33/1 03RGT35 6 Assorted Jam Tarts 03-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL Buxton Spa Bakeries Ltd. Buxton GB-DBY, GB SK179JL LOS-DO 946-0604372-0/34/1 03RGT35 6 Lemon Curd Tarts 03-JAN-2008 LACKS N/C NUTRIT LBL Britvic Soft Drinks W Midlands , GB LOS-DO 946-0603921-5/1/1 29BGT02 BASS SHANDY 24-330ML CRV 03-JAN-2008 STD IDENT LACKS N/C NUTRIT LBL Britvic Soft Drinks W Midlands , GB LOS-DO 946-0603921-5/2/1 29BCT20 IDRIS GINGER BEER 24/11.6OZ (330ML)CRV 03-JAN-2008 LACKS N/C NUTRIT LBL Glaxco Smithklein Brentford , GB TW89GS LOS-DO 946-0603921-5/3/1 29BGT02 LUCOZADE ORIGINAL BOTTLE 12/1LTR CRV 03-JAN-2008 COLOR LBLG LACKS N/C NUTRIT LBL HEALTH C Glaxco Smithklein Brentford , GB TW89GS LOS-DO 946-0603921-5/4/1 29AET01 RIBENA SPARKING B/CURRANT-CAN 24/330ML/CRV 03-JAN-2008 LACKS N/C NUTRIT LBL Britvic Soft Drinks W Midlands , GB LOS-DO 946-0603921-5/5/1 29BGT02 ROBINSON BARLEY WATER LEMON 8/1STR 03-JAN-2008 LACKS N/C NUTRIT LBL SACCHARIN Britvic Soft Drinks W Midlands , GB LOS-DO 946-0603921-5/6/1 29BGT02 ROBINSON BARLEY WATER ORANGE 2/1LTR CRV 03-JAN-2008 LACKS N/C NUTRIT LBL SACCHARIN Britvic Soft Drinks W Midlands , GB LOS-DO 946-0603921-5/7/1 29AHT02 ROBINSON BARLEY WATER PEACH 03-JAN-2008 LACKS N/C NUTRIT LBL SACCHARIN mcvities ashby-de-la-zouch GB-DBY, GB le651nz LOS-DO 946-0603921-5/16/1 03JGT02 McVites Milk Chocolate Digestives 200g 03-JAN-2008 LACKS N/C NUTRIT LBL mcvities ashby-de-la-zouch GB-DBY, GB le651nz LOS-DO 946-0603921-5/17/1 03JGT02 McVities Plain Chocolate Digestives 03-JAN-2008 LACKS N/C NUTRIT LBL McVitie's Leicestershire , GB LE65 1NZ LOS-DO 946-0603921-5/18/1 03JGT99 MCVITIES HOB NOBS 24/10.5OZ 03-JAN-2008 LACKS N/C NUTRIT LBL mcvities ashby-de-la-zouch GB-DBY, GB le651nz LOS-DO 946-0603921-5/19/1 03MFT09 MCVITIES MILK CHOC. ORANGE DIGESTIVES 12/300G 03-JAN-2008 LACKS N/C NUTRIT LBL Walkers Nonsuch Ltd Stoke-On-Trent , GB ST31QS LOS-DO 946-0603921-5/20/1 33EGT14 Walkers nonsuch Liquorice Toffees 03-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL Mars Confectionery Div Of Mars Uk Ltd Slough Berks, GB SL1 4JX LOS-DO 946-0603921-5/24/1 34FFT02 MARS DELIGHT 36/40G 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/25/1 34FFT01 CADBURY DAIRY MILK BUBBLY 48'S 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/26/1 34FFT01 CADBURY DAIRY MILK W/MINT CHIPS 12/250G 03-JAN-2008 UNSAFE COL Mars Confectionery Div Of Mars Uk Ltd Slough Berks, GB SL1 4JX LOS-DO 946-0603921-5/27/1 34FFT02 MARS MALTESERS FAMILY BAG 20/100G 03-JAN-2008 LACKS N/C NUTRIT LBL TREBOR BASSETT LTD BIRMINGHAM , GB B30 2QZ LOS-DO 946-0603921-5/29/1 33EFT11 BASSETTS MURRAY MINTS BAGS 12/200G 03-JAN-2008 LACKS N/C NUTRIT LBL TREBOR BASSETT LTD BIRMINGHAM , GB B30 2QZ LOS-DO 946-0603921-5/30/1 33EFT11 BASSETTS MURRAY MINTS ROLL 40'S 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/33/1 34FFT01 CADBURY DAIRY MILK BAR 18/250G 7OZ 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/34/1 34GGT01 CADBURY FRUIT & NUT BAR 18/250G 7OZ 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/35/1 34CFT01 CADBURY SHOLWNUT BAR 18/250G 7OZ 03-JAN-2008 LACKS N/C NUTRIT LBL Nestle Food Service York , GB Y01-1XY LOS-DO 946-0603921-5/38/1 34FFT01 NESTLE LION BAR KING SIZE 24'S 03-JAN-2008 LACKS N/C NUTRIT LBL Swizzels Matlow Limited High Peak GB-DBY, GB SK22 3HA LOS-DO 946-0603921-5/39/1 33EFT06 SWIZZLE'S LOVE HEARTS 36'S 03-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL Nestle Food Service York , GB Y01-1XY LOS-DO 946-0603921-5/40/1 34FGT01 NESTLE AERO MILK CHUNKY 36X 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/45/1 34GGT01 CADBURY FRUIT & NUT 36 X 75G POCKET PACK 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/46/1 34FFT01 CADBURY DAIRY MILK 36(75G)POCKET PACK 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/47/1 34CFT01 CADBURY WHOLENUT 18/100G 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/48/1 34FFT01 CADBURY DAIRY MILK 18/100G 03-JAN-2008 LACKS N/C NUTRIT LBL TREBOR BASSETT LTD BIRMINGHAM , GB B30 2QZ LOS-DO 946-0603921-5/50/1 33CFT14 BASSETT'S BON BON STRAWBERRY 12/8OZ 03-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL UNKNOWN UNKNOWN , TR LOS-DO 946-0603921-5/51/1 33CFT14 BASSETT'S BON BON'S LEMON 03-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL Walkers Nonsuch Ltd Stoke-On-Trent , GB ST31QS LOS-DO 946-0603921-5/54/1 33EGT14 WALKERS NON OLDE ENGLISH TOFF12/150G (BAG) 03-JAN-2008 LACKS N/C NUTRIT LBL Mars Confectionery Div Of Mars Uk Ltd Slough Berks, GB SL1 4JX LOS-DO 946-0603921-5/55/1 34FFT01 MARS MALTESERS STD BAG 40/37G 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/57/1 24VET24 PASCALL RHUBARB & CUSTARD BAGS 12/190G 03-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/58/1 33UFT02 PASCALL BLACK & RED GUMS BAGS 12/200G 03-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/59/1 33EGT14 PASCALL BLACKCURRANT & LIQUORICE BAGS 12/190G 03-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/60/1 34EFT02 PASCALL CHOCOLATE LIMES BAGS 12/190G 03-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/61/1 33EFT11 PASCALL BARLEY SUGAR BAGS 12/190G 03-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL Walkers Nonsuch Ltd Stoke-On-Trent , GB ST31QS LOS-DO 946-0603921-5/63/1 33EFT14 WALKERS NONSUCH ENGLISH ORIGINAL TOFFEE 10/100G 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Birmingham , GB LOS-DO 946-0603921-5/69/1 34FFT02 CADBURY CURLY WURLY SQUIRLY 36'S 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/70/1 33EFT06 FLYING SAUCERS 300'S 03-JAN-2008 UNSAFE COL Swizzels Matlow Limited High Peak GB-DBY, GB SK22 3HA LOS-DO 946-0603921-5/71/1 33EFT06 SWIZZELS MATLOW FRUIT FIZZERS 100'S 03-JAN-2008 UNSAFE COL COLOR LBLG LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/79/1 34CFT01 CADBURY WHOLENUT 48/49G 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/80/1 34GGT01 CADBURY FRUITS & NUTS STD 48/49G 03-JAN-2008 LACKS N/C NUTRIT LBL Mars Confectionery Div Of Mars Uk Ltd Slough Berks, GB SL1 4JX LOS-DO 946-0603921-5/82/1 34FFT02 MARS MALTESERS WHITE 25/35G 03-JAN-2008 LACKS N/C NUTRIT LBL The Wrigley Company Ltd. Plymouth GB-DEV, GB PL6 7PR LOS-DO 946-0603921-5/83/1 33UFT02 AIRWAVE SUGAR FREE GUM 30/10'S 03-JAN-2008 UNSAFE COL COLOR LBLG LACKS N/C NUTRIT LBL The Jacob'S Bakerly Ltd. Liverpool , GB L97BQ LOS-DO 946-0603921-5/85/1 07AGT07 JACOBS TWIGLETS ORIGINAL 12'S/5GMBAGS 03-JAN-2008 LACKS N/C NUTRIT LBL Walkers Nonsuch Ltd Stoke-On-Trent , GB ST31QS LOS-DO 946-0603921-5/94/1 33EFT14 WALKERS NONSUCH OLD ENG ROYAL TOFF(BAG)1/2.5KG 03-JAN-2008 LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/95/1 33JGT12 BASSETTS JELLY BABIES 12/215G 03-JAN-2008 UNSAFE COL COLOR LBLG LACKS N/C NUTRIT LBL unknown unknown , ES LOS-DO 946-0603921-5/98/1 33CFT06 BASSETTS PEAR DROPS 12/200G 03-JAN-2008 UNSAFE COL COLOR LBLG LACKS N/C NUTRIT LBL Cadbury Trebor Bassett Birmingham GB-BIR, GB B302JT LOS-DO 946-0603921-5/99/1 33CGT12 BASSETTS ALLSORTS DESSERT 12/200G 03-JAN-2008 UNSAFE COL COLOR LBLG LACKS N/C NUTRIT LBL Kerry Foods Ltd Surrey , GB LOS-DO 946-0603921-5/111/1 03SGT40 GREENS YORKSHIRE/BATTER MIX 12/4.5OZ 03-JAN-2008 LACKS N/C NUTRIT LBL H.J.Heinz Company Limited Middlesex , GB LOS-DO 946-0603921-5/116/1 03NET04 HEINZ CHOC SPONGE PUD TIN 6/10.5OZ 300G 03-JAN-2008 LACKS N/C NUTRIT LBL NEEDS FCE H.J.Heinz Company Limited Middlesex , GB LOS-DO 946-0603921-5/117/1 03NET04 HEINZ CADBURY CHOC SPONGE PUD TIN 300 ML 03-JAN-2008 LACKS N/C NUTRIT LBL NEEDS FCE H.J.Heinz Company Limited Middlesex , GB LOS-DO 946-0603921-5/118/1 03NET04 HEINZ STRAW SPNG PUD TIN 6/10.5OZ 03-JAN-2008 LACKS N/C NUTRIT LBL NEEDS FCE H.J.Heinz Company Limited Middlesex , GB LOS-DO 946-0603921-5/119/1 03NET04 HEINZ STICKY TOFFEE PUDDING 6/310G 03-JAN-2008 LACKS N/C NUTRIT LBL NEEDS FCE Unknown Unknown , NL LOS-DO 946-0603921-5/122/1 37JCE23 UNCLE BEN'S KORMA SAUCE 6-14OZ (500G) 03-JAN-2008 LACKS N/C NUTRIT LBL NEEDS FCE Premier Foods Limited (Long Sutton Site) Spalding , GB PE129EQ LOS-DO 946-0603921-5/140/1 25LGH06 SMASH INSTANT POTATOES ORIG 12/88G 03-JAN-2008 LACKS N/C NUTRIT LBL Unilever Bestfoods Esher , GB LOS-DO 946-0603921-5/158/1 37KCT99 MARMITE 12/9OZ (250G) 03-JAN-2008 LACKS N/C NUTRIT LBL NEEDS FCE Unilever Bestfoods Esher , GB LOS-DO 946-0603921-5/159/1 37KCT99 MARMITE 6/17.5OZ (500G) 03-JAN-2008 LACKS N/C NUTRIT LBL NEEDS FCE Premier Foods Limited (Long Sutton Site) Spalding , GB PE129EQ LOS-DO 946-0603921-5/160/1 16YCT03 SHIPPAMS SALMON SPREAD 12/1.2OZ(35G) 03-JAN-2008 UNSAFE COL COLOR LBLG LACKS N/C NUTRIT LBL NEEDS FCE H.J.Heinz Company Limited Middlesex , GB LOS-DO 946-0603921-5/163/1 27ACT03 HEINZ SALAD CREAM SQUEEZY(LARGE)12/22OZ(650G) 03-JAN-2008 LACKS N/C NUTRIT LBL NEEDS FCE Unknown Unknown , NL LOS-DO 946-0603921-5/165/1 37JCT07 HP SAUCE SQUEEZY BOTTLE 12/16 OZ 425G 03-JAN-2008 LACKS N/C NUTRIT LBL Premier Foods Limited (Long Sutton Site) Spalding , GB PE129EQ NYK-DO DP4-0420154-4/6/1 37JCE07 HOMEPRIDE COOK IN CURRY SAUCE 07-JAN-2008 NEEDS FCE Meditech Industries Sheffield , GB S103RX CIN-DO 110-1231824-8/1/1 66VDY99 DIETARY SUPPLEMENT SKIN PATCH FOR WIEGHT CONTROL-CALLED HOOD 08-JAN-2008 UNAPPROVED Masterfoods, Div. of Mars U.K. Ltd Bershire Gb-Nota, GB SL14JX FLA-DO 406-0408482-8/1/8 34FFY01 MARS MINSTRELS 08-JAN-2008 UNSAFE COL Lamez Ltd London , GB EC1M3JB NOL-DO 112-7504252-3/1/1 79L--MH 940434411543 DERMAL IMPLANT 11-JAN-2008 RX DEVICE Generics Uk Ltd Hertfordshire , GB NYK-DO 112-0660289-1/1/1 62KCB10 792469353510 OMEPRAZOLE CAPSULES 20MG 15-JAN-2008 UNAPPROVED Bhr Pharmaceuticals Ltd Nuneaton , GB NYK-DO 112-0971301-8/1/1 82N--IG 857454280597 PANCREATITIS TESTS 15-JAN-2008 NOT LISTED NO 510(K) Abbey Export Ltd Leeds , GB PHI-DO 110-1281512-8/1/1 68YIP10 Synacthen Amps 0.25mg/ml 16-JAN-2008 NEW VET DR Hartington Chemical Deeside, Clywd Wales, GB CH5 2PH MIN-DO XXX-0153177-2/1/1 60LCB99 Paracetamol Biogesic 500mg Tablets 22-JAN-2008 UNAPPROVED Ess Lab Hadleigh Esse , GB NOL-DO 112-0983090-3/1/1 78F--CG 861497749843 NEEDLES 23-JAN-2008 NOT LISTED Nestle Food Service York , GB Y01-1XY LOS-DO 946-0603922-3/85/1 33LFT12 ROWNTREE'S FRUIT PASTILLES GIANT TUBE (W)12 28-JAN-2008 LACKS N/C NUTRIT LBL Premier Foods Limited (Long Sutton Site) Spalding , GB PE129EQ LOS-DO 946-0603923-1/16/1 25YET99 NEW POTATOES IN WATER 28-JAN-2008 NEEDS FCE NO PROCESS Sara Lee Household & Body Care Slough FN, GB LOS-DO 946-0603923-1/6/1 53BD-01 STRESS RELIEF HERBAL BATH 28-JAN-2008 NOT LISTED Reckitt Benkiser Ltd Swindon , GB SN57XZ LOS-DO 946-0603923-1/3/1 53LC-99 DETTOL DISINFECTATNT-LIQUID 12/9 OZ (250ML) 28-JAN-2008 NOT LISTED Iceland Frozen Foods Deeside Flintshire , GB CH52NW LOS-DO 946-0604372-0/11/1 03THT40 12 Original Yorkshire Puddings Light & Crispy Ready in 4 min 28-JAN-2008 LACKS N/C NUTRIT LBL Old Fashioned Foods (UK) Ltd London GB-LND, GB SW82QZ LOS-DO 946-0604460-3/58/1 03RGT03 AUNTYS FESTIVE PLUM PUD 2X110G 28-JAN-2008 UNSAFE COL LACKS N/C NUTRIT LBL YELLOW #5 Fiddes Payne Ltd Banbury GB-OXF, GB OX164SP LOS-DO 946-0604460-3/68/1B 03UFT01 CHRISTMAS CAKE DECORATING KIT 28-JAN-2008 UNSAFE COL LING'S LONDON , GB N226TS LOS-DO 946-0604460-3/81/1 33LFT05 LING TURK DEL ROSE & LEM 325G 28-JAN-2008 UNSAFE COL HARRINGTONS CHOCOLATES PORT MELBOURNE Victoria, AU 3207 LOS-DO 946-0604460-3/82/1 34CFT02 SUGARED ALMONDS 28-JAN-2008 UNSAFE COL Ktd (Edibles) Ltd Wednesbury , GB WS107DE SWI-DO KM6-0105279-8/21/1 26CCT99 ALMOND OIL 29-JAN-2008 LACKS FIRM LABELING NUTRIT LBL HARROW DRUG CO. MIDDLESEX , GB SWI-DO KM6-0105279-8/22/1 26CGT09 SESAME OIL 29-JAN-2008 LACKS FIRM LABELING NUTRIT LBL