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
PZ CUSSONS
Stockport Sk3 Oyl, GB SWI-DO KM6-0105279-8/13/4
53JY-01 IMPERIAL LEATHER
06-FEB-2008 CSTIC LBLG
COSMETLBLG
COSMETLBLG
PREEMA INT. LTD
JB , GB SWI-DO KM6-0105279-8/24/1
50BGT01 FOOD COLOR RED
06-FEB-2008 UNSAFE COL
PREEMA INT. LTD
JB , GB SWI-DO KM6-0105279-8/24/2
50BGT01 FOOD COLOR YELLOW
06-FEB-2008 UNSAFE COL
PREEMA INT. LTD
JB , GB SWI-DO KM6-0105279-8/24/3
50BGT01 FOOD COLOR GREEN
06-FEB-2008 UNSAFE COL
PREEMA INT. LTD
JB , GB SWI-DO KM6-0105279-8/24/4
50BGT01 FOOD COLOR ORANGE
06-FEB-2008 UNSAFE COL
PREEMA INT. LTD
JB , GB SWI-DO KM6-0105279-8/24/5
50BGT01 FOOD COLOR PINK
06-FEB-2008 UNSAFE COL
Universal Studios
London , GB SW208LT NOL-DO 112-0988670-7/4/1
85H--IS 924260078099 CONDONS
06-FEB-2008 NOT LISTED
NO 510(K)
All Bagged Up Latd
Reading , GB RG75AN NOL-DO 112-1152169-8/1/1
53MA-99 659744943574/SPORTS SUNSCREEN
07-FEB-2008 NOT LISTED
Elemis Ltd Whse & Distribution
Somerset , GB FLA-DO MA7-0683583-6/3/1A
66VDY99 Cal-Metab Plus (Elemis)
07-FEB-2008 UNAPPROVED
Elemis Ltd Whse & Distribution
Somerset , GB FLA-DO MA7-0683583-6/3/1B
66VDY99 Cellular Recovery Skin Bliss Capsules
07-FEB-2008 UNAPPROVED
Elemis Ltd Whse & Distribution
Somerset , GB FLA-DO MA7-0683583-6/3/1C
66VDY99 A & B Slimming Ampoules
07-FEB-2008 UNAPPROVED
Mcneil Gmbh & Co
Bad Honnef , GB D-53604 NOL-DO 112-1173674-2/2/1A
62KAA08 855490102687/IMODIUM 2MG
07-FEB-2008 UNAPPROVED
Morocargo Uk Ltd
London , GB NYK-DO AR8-2001053-6/3/1
63VBJ02 Clear touch number one
12-FEB-2008 UNAPPROVED
Pumphouse Gb Ltd
West Yorkshire , GB NOL-DO 112-8165242-2/1/1
79F--GY 929206168338 CANNULAS
12-FEB-2008 NOT LISTED
Pumphouse Gb Ltd
West Yorkshire , GB NOL-DO 112-8165242-2/2/1
65RCN12 929206168338 SALINE
12-FEB-2008 NOT LISTED
Pumphouse Gb Ltd
West Yorkshire , GB NOL-DO 112-8165242-2/2/2
65RCN12 929206168338 SALINE
12-FEB-2008 NOT LISTED
Pumphouse Gb Ltd
West Yorkshire , GB NOL-DO 112-8165242-2/2/3
60QAY07 929206168338 XYLOCAINE
12-FEB-2008 AGR RX
Pumphouse Gb Ltd
West Yorkshire , GB NOL-DO 112-8165242-2/4/1
79J--CY 929206168338 CATHETERS
12-FEB-2008 NOT LISTED
Advanced Microderm
Schaumburgschaumburg, IL 60193 FLA-DO MA7-0683980-4/2/1B
65RAR18 Sodium Bicarbonate
14-FEB-2008 WARNINGS
Elemis Ltd Whse & Distribution
Somerset , GB FLA-DO MA7-0683980-4/2/1A
54AEF90 CAPSULES ANTI AGE
14-FEB-2008 DIETARYLBL
NUTRIT LBL
H.J.Heinz Company
Wigan , GB LOS-DO M96-2069858-6/6/1
27BCT99 36 CASES PICCALLI PICKLE 275
14-FEB-2008 NEEDS FCE
NO PROCESS
Intellectual Brands
London , GB NW18BB NOL-DO 112-1210716-6/1/1A
53EC-99 Disorder
14-FEB-2008 COSMETLBLG
Intellectual Brands
London , GB NW18BB NOL-DO 112-1210716-6/1/1B
53EC-99 The Daddy
14-FEB-2008 COSMETLBLG
Intellectual Brands
London , GB NW18BB NOL-DO 112-1210716-6/1/1C
53EC-99 lARGE IT
14-FEB-2008 COSMETLBLG
Intellectual Brands
London , GB NW18BB NOL-DO 112-1210716-6/2/2
53ED-99 Reconstruct
14-FEB-2008 UNSAFE COL
Nisa International
Grimsby , GB DN311SJ LOS-DO GX5-9915910-8/4/1
03RGT50 4 LARGE YORKSHIRE PUDDINGS
15-FEB-2008 LACKS N/C
TRANSFAT
LABELING
Nisa International
Grimsby , GB DN311SJ LOS-DO GX5-9915910-8/4/3
03RGT50 12 ORIGINAL YORKSHIRE PUDDINGS
15-FEB-2008 LACKS N/C
TRANSFAT
LABELING
Medicus Maximus Ltd
Essex , GB NOL-DO 112-1272010-9/1/1
85H--IH 861141436568/HYPTEROSCOPE
15-FEB-2008 NOT LISTED
NO 510(K)
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO 112-1073883-0/4/2
53CH-03 RML Color Rush Quad Chocolate
21-FEB-2008 POISONOUS
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO 112-1073883-0/4/3
53CH-03 RML Colour Rush Quad Almond
21-FEB-2008 POISONOUS
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO 112-1073883-0/4/4
53CH-03 RML Colour Rush Quad- Cafe Latte
21-FEB-2008 POISONOUS
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO 112-1073883-0/4/5
53CH-03 RML Colour Rush Quad -Bronzed
21-FEB-2008 POISONOUS
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO 112-1075406-8/2/8
53CK-03 RMLSS Gltr Eye Shadow Pencil-SB
21-FEB-2008 POISONOUS
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO 112-1075406-8/2/9
53CK-03 RML SS Gltr Eye Shadow Pencil-TWI
21-FEB-2008 POISONOUS
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO 112-1075406-8/2/10
53CK-03 RML SS Gltr Eye Shadow pencil SD
21-FEB-2008 POISONOUS
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO 112-1075406-8/2/17
53CH-03 RML Cologne Rush Duo Eye shadow
21-FEB-2008 POISONOUS
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO 112-1075406-8/2/18
53CH-03 RML Colour Rush Quad Eye shadow
21-FEB-2008 POISONOUS
Organic Trevarno
Helstonhelston , GB TR130 NOL-DO 112-1277318-1/1/10
53KD-01 953919410150.AFTERSHAVE OIL
22-FEB-2008 LABELING
Organic Trevarno
Helstonhelston , GB TR130 NOL-DO 112-1277318-1/1/1
53LY-01 953919410150.BABY CREAM
22-FEB-2008 LABELING
Organic Trevarno
Helstonhelston , GB TR130 NOL-DO 112-1277318-1/1/3
53LY-01 953919410150.FACIAL OIL
22-FEB-2008 CSTIC LBLG
LABELING
Organic Trevarno
Helstonhelston , GB TR130 NOL-DO 112-1277318-1/1/5
62QBJ99 953919410150 Organic Rosemary Ointment, Rose & Jojoba moistu
22-FEB-2008 NOT LISTED
DIRECTIONS
N-RX INACT
DRUG NAME
Organic Trevarno
Helstonhelston , GB TR130 NOL-DO 112-1277318-1/1/6
66PBY99 953919410150 Orgainc elements spf 15 protection balm sun, se
22-FEB-2008 NOT LISTED
N-RX INACT
DRUG NAME
Organic Trevarno
Helstonhelston , GB TR130 NOL-DO 112-1277318-1/1/7
53LY-01 953919410150.LIP BALM
22-FEB-2008 CSTIC LBLG
LABELING
Organic Trevarno
Helstonhelston , GB TR130 NOL-DO 112-1277318-1/1/8
53LY-01 953919410150.LIP BALM
22-FEB-2008 CSTIC LBLG
COSMETLBLG
Organic Trevarno
Helstonhelston , GB TR130 NOL-DO 112-1277318-1/1/9
53HC-03 953919410150 Organic nail conditioner
22-FEB-2008 LABELING
Organic Trevarno
Helstonhelston , GB TR130 NOL-DO 112-1277318-1/1/11
53LY-01 953919410150.BABY CLEANSER
22-FEB-2008 LABELING
COSMETLBLG
Charbonnel Et Walk
Turnbridge We , GB NOL-DO 112-1299207-0/1/1A
34YFY99 #1 Chocolat Charbonnel Chocolate Drink.
22-FEB-2008 LIST INGRE
Charbonnel Et Walk
Turnbridge We , GB NOL-DO 112-1299207-0/1/1B
34YFY99 Pink Marc Champagne, Plain Marc, Milk Praline, Plain Caramel
22-FEB-2008 NUTRIT LBL
Charbonnel Et Walk
Turnbridge We , GB NOL-DO 112-1299207-0/1/1C
34YFY99 PINK MARC DE CHARBONNEL TRUFFLES
22-FEB-2008 COLOR LBLG
NUTRIT LBL
Charbonnel Et Walk
Turnbridge We , GB NOL-DO 112-1299207-0/1/1D
34YFY99 MILK MARC DE CHARBONNEL AND COCOA DUSTED MILK CHOCOLATE AND
22-FEB-2008 NUTRIT LBL
Boxer Games
West Yorkshire , GB NOL-DO 112-1346887-2/1/1
53LD-99 861497826710 Lovers Body Pen Sets
22-FEB-2008 UNSAFE COL
Preema Intl Ltd
Middlex , GB UB67JB SWI-DO 512-1002696-2/7/1
50DYY03 RED PODWER
25-FEB-2008 UNSAFE COL
Atums Pvt Ltd
London , GB NOL-DO 112-0050166-9/1/1
60TDP99 792448380115/HUMIRA
25-FEB-2008 UNAPPROVED
Serp
Castelsarrasin , FR 82100 FLA-DO MA7-0629938-9/1/1A
66VBL99 Formule A + B
26-FEB-2008 UNAPPROVED
Serp
Castelsarrasin , FR 82100 FLA-DO MA7-0629938-9/1/1B
53LD-99 Afina-Slimming Gel
26-FEB-2008 COSMETLBLG
COSMETLBLG
Serp
Castelsarrasin , FR 82100 FLA-DO MA7-0629938-9/2/1A
53LD-06 Surcreme
26-FEB-2008 COSMETLBLG
Serp
Castelsarrasin , FR 82100 FLA-DO MA7-0629938-9/2/1B
53LD-06 Aferligne
26-FEB-2008 COSMETLBLG
COSMETLBLG
Serp
Castelsarrasin , FR 82100 FLA-DO MA7-0629938-9/6/1
53LD-09 TONERS
26-FEB-2008 COSM COLOR
Steiner Transocean Ltd
Middx , GB HA36BZ FLA-DO MA7-0629938-9/7/1
76M--AU GENTLE WHITE PROFESSIONAL KIT
26-FEB-2008 NOT LISTED
REGISTERED
Jalpur Millers
Leicester , GB LE46NP SWI-DO KM6-0105279-8/25/1
02GGT99 BAJRI FLOUR
28-FEB-2008 FILTHY