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Home Products Manufacturers Ingredients Health Effects

Food and Drug Administration Actions:
Recalls and Field Corrections
2002-February 1, 2007

FDA Media Inquiries: 301-827-6242
FDA Consumer Inquiries: 888-INFO-FDA
FDA Website: www.fda.gov
FDA Recalls, Product Withdrawals, and Safety Alerts



1.
Lubriderm Moisture Mitts-2007
2.
Anastasia Diabetic Skin Care Therapy Hand & Body Treatment-2007
3.
AVEENO Positively Radiant Triple Boosting Serum-2006
4.
DDF Doctor's Dermatologic Formula, Organic-2006
5.
Shampoo caps with conditioner-2006
6.
Medline Alcohol-Free Mouthwash-2006
7.
NOW XyliWhite Mouthwash-2006
8.
John Frieda brand brilliant brunette, Starlit Waves, Wave Enhancing Spray-2006
9.
Medline Baby Lotion -2005
10.
Starbrite brand Black Magic Color Tattoo Ink -2005
11.
Premier True Color Pigments in 0.5oz containers-2005
12.
Design a Face Make-up-2005
13.
"Baby Wipe" and Triad "Cleansing Wipes" brands-2005
14.
Cran brand Face Paint, 5 colors-2005
15.
Medication Mardel biospheres Maracide for Ick, Velvet, and other external Parasites-2005
16.
Deluxe Dish Detergent Antibacterial Hand Soap-2005
17.
John Frieda Professional Hair Styling Spray, Sheer Blonde, Curvaceous Blonde-2004
18.
Orasept Antiseptic Mouthwash & Gargle -2004
19.
Colgate Fluoride Toothpaste-2004
20.
Medline Baby Lotion -2004
21.
Clare Burke Lathering Scrubs-2004
22.
Sebolux Medicated Shampoo for Dogs and Cats & Epi-Otic Ear Cleanser for dogs, cats, puppies, and kittens
23.
C.E.T. Home Dental Care Oral Hygiene Gel for Dogs and Cats-2004
24.
John Frieda brand Sheer Blonde Curvaceous Blonde Curl-Defining Styler-2004
25.
Pantene PRO-V shampoo (various)-2004
26.
Breath-eze Breath and Gas Relief Tablets for Dogs-2004
27.
Top Care® Distilled Extract of Witch Hazel & Top Care® Hydrogen Peroxide Solution-2004
28.
John Frieda Frizz Ease 5-Minute Manager Blow Dryer Styling Spray -2004
29.
Chunkie Face Paints-2003
30.
Coppertone Bug & Sun Sunscreen with Insect Repellent, SPF 30, Kid's Formula-2003
31.
Ray Block Sunscreen Lotion, SPF 15-2003
32.
Don't Be Bald Hair Care Treatment, Medicated; BBD 1854 Dandruff Shampoo; and Don't Be Bald, Scalp Stimulate-2003
33.
The Skin Culture One Day Peeling Treatment and The 6 Day Cosmetic Facial Treatment Kit-2003
34.
Pert Plus, 2 in 1 Dandruff Control Shampoo plus Conditioner-2003
35.
Anti-Aging Wrap solution-2002
36.
Physicians Formula, Eye Makeup Remover Lotion-2002
37.
Rejuvenating Mist, manufactured for Soroko Blade Laboratories-2002
38.
HAND MEDIC Antiseptic Skin Treatment-2002
39.
PROVON Medicated Lotion Soap (GoJo)-2002
40.
Royal Jelly Milk Balm Moisture Lotion-2002
41.
GOJO Skin Lotion Medicated-2002
42.
Aura Cacia Rich Moisturizing Shampoo-2002
43.
Softsoap Antibacterial Liquid Hand Soap (with hand pump)-2002
44.
Listerine Essential Care Gel Toothpaste and Listerine Essential Care Tartar Control Gel Toothpaste-2002
45.
Hartz Advanced Care Brand Flea Control Capsules-2002
46.
Paradise Gold SUNSCREEN BROAD SPECTRUM PROTECTANT-2002
47.
Pyrethrin Lice Treatment, Kinray Preferred Plus brand, A Creme Rinse Application-2002

 

January 24, 2007 Lubriderm Moisture Mitts, Skin Moisturizing Lotion-2007
PRODUCT Lubriderm Moisture Mitts, skin moisturizing lotion: a) Lubriderm Moisture Mitts 15 ct. - Case UPC: 50052800489405; Lubriderm Mitt Unit UPC: 052800489400 Promotional Display -Lubriderm Moisture Mitts 15 ct 12 pc PDQ: Case UPC: 00052800928343; Lubriderm Mitt Unit UPC: 0528009489400;
b) Lubriderm Moisture Mitts 15 ct 12 pc PDQ: Case UPC: 00052800929388, Luriderm Mitt Unit UPC: 05200489400 Promotional Display -Lubriderm MX 16 oz w/Lubriderm Mitt 15 ct & IRC x18PDQ display containing: 6 boxes of 15 single use mitts 4 bottles of Lubriderm Nourishing Lotion 16 oz., 4 bottles Lubriderm Advanced Therapy Moisturing Lotion 16 oz., 4 bottles Lubriderm Skin Nourishing Moisturizing Lotion with Sea Kelp 16 oz: Case UPC 00052800927810, Lubriderm Mitt Unit UPC: 052800489400;
c) Promotional Display - Lubriderm MX 19.6 oz. & Lubriderm Mitts 15 ct x 24 PDQ Display containing: 6 boxes of 15 single use mitts, 6 bottles Lubriderm Advanced Therapy Moisturizing Lotion 19.6 oz., 6 bottles Lubriderm Daily Moisturizing Lotion 19.6 oz., 6 bottles of Lubriderm Skin Moisturizing Lotion with Sea Kelp 19.6 oz. Case UPC 00052800927902, Lubriderm mitt Unit UPC 052800489400;
d) Lubriderm Moisture MItts UPC 052800489400, each case contains boxes of 12 mitts,
Recall # F-093-7
CODE a) Case Lot #'s: 00286SD2, 00386SD1, 00386SD2, 00986SD1, 00986SD1A, 01086SD1, 01086SD2, 01186SD1, 01486SD1, 01586SD1, 01686SD1, 0168SD1, 0186SD1;
b) Case lot #'s: 00196SD1, 03086SD1, 03086SD2, 03186SD1, 03186SD2;
c) Case lot #''s 00896SD1, 01196SD1, 01296SD1, 01296SD2, 01396SD1, 01396SD2, 01496SD1, 01496SD2, 01596SD1, 01596SD2, 02196SD1;
d) Lot #'s: 171602, 172602, 173602, 174602, 174601, 175601, 175603, 177603, 177604, 177605, 178605, 181605, 182605, 183605, 186605, 187605, 188605, 189605, 191606,192606, 193606, 194606, 195606, 196606, 198606, 199606, 200606, 200607, 201607, 202607, 203607, 205607, 206607, 207607, 208608, 209608, 210608, 212608, 213608, 215608, 216608, 219608, 220609, 212609, 222609, 227609, 230609, 233609
RECALLING FIRM/MANUFACTURER Recalling Firm: Pfizer, Inc., Morris Plains, NJ, by mailing notification packages on October 11, 2006.
Manufacturer: Pacon Manufacturing Corp., Somerset, NJ. Firm initiated recall is ongoing.
REASON Lubriderm Moisture Mitts were tested and found to contain mold - Aspergillus fumigatus, Aspergillus versicolor, and Penicillium sp.
VOLUME OF PRODUCT IN COMMERCE 24,069 cases of 12 mitts each (288,828 mitts)
DISTRIBUTION Nationwide

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January 3, 2007 Anastasia Diabetic Skin Care Therapy Hand & Body Treatment-2007
PRODUCT Anastasia Diabetic Skin Care Therapy Hand & Body Treatment, 4 oz. jar, Recall # F-083-7
CODE Lot #2000D6
RECALLING FIRM/MANUFACTURER Recalling Firm: Anastasia Marie Laboratories, Inc., Oklahoma City OK., by telephone and letter beginning October 13, 2006.
Manufacturer: American Pharmaceuticals & Cosmetics, Inc., Fort Worth, TX. Firm initiated recall is ongoing.
REASON Hand & Body Cream is contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE 1,481- 4oz. jars
DISTRIBUTION Nationwide

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January 25, 2006 DDF Doctor's Dermatologic Formula, Organic-2006
PRODUCT a) DDF Doctor's Dermatologic Formula, Organic
Sun Protection SPF 30 --- for Sensitive
Skin --- Super Antioxidant Complex, Oil &
Fragrance-Free --- Meets EU Standards for
UVA --- net wt. 4 oz. 113.4 g --- Active
ingredients: Titanium Dioxide 2.5% ---
Zinc Oxide 4%, UPC 0 60748 00040 3,
Recall # D-129-6;
b) DDF Doctor's Dermatologic Formula, Moisturizing
Photo-Age Protection SPF 30, Delays Skin Aging,
Restores Moisture --- Super Antioxidant Complex,
Meets EU Standards For UVA, net. wt. 4 oz. 113.4 g,
Active ingredients: Avobenzone 1%, Octinoxate 7.5%,
Octisalate 5%, Octocryene 6%, UPC 0 60748 00039 7,
Recall # D-130-6;
c) DDF Doctor's Dermatologic Formula, Matte Finish,
Photo-Age, Protection SPF 30 --- Minimizes Shine,
Super Antioxidant Complex, Oil and Fragance-Free,
Meets EU Standards for UVA, net wt. 4 oz. 113.4 g,
Active ingredients: --- Avobenzone 1% --- Octinoxate
7.5% --- Octisalate 5% --- Octocrylene 6%,
UPC 0 60748 00038 0, Recall # D-131-6;
d) DDF Doctor's Dermatologic Formula, Protective Eye
Cream SPF 15 --- 0.5 fl. oz. 15 ml --- Active
ingredient: Octinoxate 5% --- Octisalate 1% ---
Zinc Oxide 2%, Recall # D-132-6;
e) DDF Doctor's Dermatologic Formula, Fade Gel 4 ---
Hydroquinone 2% --- Proven Lightener, Evens Skin
Tone --- Fades Age Spots --- 0.5 fl. oz. 15 ml ---
Active Ingredient: Hydroquinone 2%, UPC bar code
0 60748 00032 8, Recall # D-133-6;
f) DDF Doctor's Dermatologic Formula, Fade Cream,
SPF 30 --- Hydroquinone 2%, Minimizes Age Spots,
Prevents Recurrence, Enriched Moisturizer,
net wt. 1.7 oz. 48 g -- Active Ingredients:
Avobenzone 1% --- Hydroquinone 2% --- Octinoxate
7.5% --- Octisalate 4% --- Octocrylene 5% ---
Oxybenzone 1.5%, UPC 0 60748 00030 4,
Recall # D-134-6;
g) DDF Doctor's Dermatologic Formula, Glossy Lip
Therapy, SPF 15 --- Plumps --- Protects ---
Moisturizes, net wt. 0.25 oz. 7 g --- Active
Ingredients: Octinoxate 5% --- Octisalate 3% ---
titanium Dioxide 1%, UPC bar code 0 60748 00041 0,
Recall # D-135-6
CODE All lots & sizes on the market
RECALLING FIRM/MANUFACTURER Recalling Firm: HDS Cosmetics, Inc., Yonkers, NY, by telephone on November 11, 2005 and by letters on November 30, 2005.
Manufacturer: HDS Cosmetics, Inc., Harrison, NY. Firm initiated recall is ongoing.
REASON Firm does not have adequate stability data to support 2 year expiry period for the OTC products.
VOLUME OF PRODUCT IN COMMERCE Approx. 218,189 units
DISTRIBUTION Nationwide

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February 22, 2006 Shampoo caps with conditioner -2006
PRODUCT a) Shampoo caps with conditioner, 1 disposable
shampoo cap per package, 30 packages per case.
The shampoo caps are manufactured under the
following labels: (1) CompleteBath,
(2) ReadyBath, and (3) No Rinse Shampoo Cap,
Recall # F-068-6;
b) No-Rinse Shampoo Cap, Shampoo & Condition
Hair with Absolutely No Water, No Mess,
No Rinsing. Recall # F-069-6
CODE

All inventory manufactured prior to 10/27/05. An example of the code would be A102705 or B102705.

RECALLING FIRM/MANUFACTURER ICP Medical, Olivette, MO, by letter dated October 26, 2005 and November 2, 2005, and by press release on October 31, 2005. Firm initiated recall is ongoing.
REASON Shampoo caps may be contaminated with Serratia marcescens.
VOLUME OF PRODUCT IN COMMERCE Approximately 10,962/30-cap cases
DISTRIBUTION IL, OH, and MO

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March 29, 2006 Medline Alcohol-Free Mouthwash -2006
PRODUCT Medline Alcohol-Free Mouthwash, Reorder numbers: MDS095029 for 2-oz. size and MDS095030 for 4-oz. size. Manufacturer’s Code is RA05CRR, UPC Code for 2-oz. product is 0 8019616684 1, UPC Code for 4-oz. product is 0 8019674536 7, Recall # F-092-6
CODE All products with lot codes beginning with the numbers 0503 through 0508 followed by 3 or 4 additional digits.
RECALLING FIRM/MANUFACTURER Carrington Laboratories, Inc., Irving, TX, by fax on August 23, 2005 and by letter on August 25, 2005, firm initiated recall is ongoing.
REASON Alcohol-free mouthwash is contaminated with Burkholderia cepacia and is associated with an illness outbreak.
VOLUME OF PRODUCT IN COMMERCE 21,504-2 oz. bottles and 129,000 4-oz. bottles
DISTRIBUTION Nationwide

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May 10, 2006 John Frieda Hair Sprays -2006
PRODUCT John Frieda brand brilliant brunette, Starlit Waves, Wave Enhancing Spray packaged in a 6 fl. oz (177 ml) pump spray bottle. The product is packed and distributed a 6 x 6 fl. oz bottles per case. The cases are labeled as brilliant brunette, 10947-00, Starlit Waves Wave Enhancing Spray, and contain a UPC code of: 1 07 17226 0947 5. The case labeling also reads: JOHN FRIEDA PROFESSIONAL HAIR CARE. Recall # F-160-6
CODE Lot #''s T314BM27, T315BM27, T316BM29, T317BM29, T317BM30, T318BM30, T004BM53, T005BM53, T006BM53, T007BM53, T008BM52, T008BM49, T009BM49, V022BM63, V023BM63, V024BM42 & V025BM43
RECALLING FIRM/MANUFACTURER Recalling Firm: KAO Brands Company, Cincinnati, OH, by letter on February 23 and 24, 2006.
Manufacturer: Les Emballages Knowlton Inc., Canada. Firm initiated recall is ongoing.
REASON Hair Spray is contaminated with Pseudomonas.
VOLUME OF PRODUCT IN COMMERCE 17,232 cases [103,392 bottles]
DISTRIBUTION Nationwide

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May 10, 2006 NOW XyliWhite Mouthwash -2006
PRODUCT NOW XyliWhite Mouthwash; an all natural, fluoride-free oral rinse; 16 fl. oz. plastic bottles with a foil seal, 9 bottles and 20 bottles per carton, UPC 33739-08095, Recall # F-152-6
CODE Lot numbers 735906 and 736424
RECALLING FIRM/MANUFACTURER NOW Foods, division of The Fruitful Yield, Inc., Bloomingdale, IL by letter dated March 10, 2006. Firm initiated recall is ongoing.
REASON A breakdown in the product's preservative system allowed the growth of Enterobacter gergoviae bacteria in the mouthwash
VOLUME OF PRODUCT IN COMMERCE 1,266 bottles
DISTRIBUTION Nationwide

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July 5 , 2006 AVEENO Positively Radiant Triple Boosting Serum -2006
PRODUCT AVEENO Positively Radiant Triple Boosting Serum. 1.7 fl oz and .25 fl oz. Recall # F-229-6
CODE All lots
RECALLING FIRM/MANUFACTURER Recalling Firm: Johnson & Johnson Consumer Products Co., Skillman, NJ, by letter on May 17, 2006.
Manufacturer: Vee Pak Inc., Countryside, IL, firm initiated recall is ongoing.
REASON Triple Boosting Serum is contaminated with Enterobacter gergoviae.
VOLUME OF PRODUCT IN COMMERCE 242735 1.7 fl oz plastic pump containers/154944 0.25 fl oz plastic tubes
DISTRIBUTION Nationwide and Internationally

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March 23, 2005 Medline Baby Lotion -2005
PRODUCT a) Medline Baby Lotion, packaged in 2 fl. oz. bottles,
96/case (reorder MSC095007) and 4 fl. oz. bottles,
60/case (reorder MSC095018); Made in U.S.A.; the
bottles were sold separately or as components of
custom admission kits or complete delivery systems
(CDS) containing an admission kit. Recall # F-218-5.
b) Medline Hand & Body Lotion, packaged in 2 fl. oz.
bottles, 96.case (reorder MSC095001) and 4 fl. oz.
bottles, 60/case (reorder MSC095004) bottles;
Made in U.S.A.; the bottles were sold separately or
as components of custom admission kits or complete
delivery systems (CDS) containing an admission kit.
Recall # F-219-5;
c) Soothe & Cool Cleansing Bath Oil, packaged in
3.5 fl. oz. bottles, 96/case (reorder MSC090472)
and 1 gallon bottles, 4/case (reorder MSC090474);
Made in U.S.A.; the bottles were sold separately or
as components of custom admission kits.
Recall # F-220.5;
d) Medline Baby Oil, packaged in 2 fl. oz. bottles,
96/case (reorder MSC095050), 4 fl. oz. bottles
60/case (reorder MSC095052), 8 fl. oz. bottles,
36/case (reorder MSC095054) and 16 fl. oz. bottles,
12/case (reorder MSC095056 and MSC095056H); Made
in U.S.A.; the bottles were sold separately or as
components of custom admission kits or complete
delivery systems (CDS) containing an admission kit.
Recall # F-221-5.
CODE a) All bottle lots beginning with a "3" or 4001, 4002,
4003, 4004, 4005, 4006, 4007, 4008, or have no lot
number. The following kit reorder numbers contain
2 oz. bottles of baby lotion: DYK1001437A1,
DYK1001831D, DYK1004191B, DYK1004272A, DYK1005268A1,
DYK1005268A2, DYK1005268A3, DYK1005389B, DYK1005489B1,
DYK1005577B1, DYK1005969B, DYK1006010B, DYK1008593B,
DYK1008830B1, DYK1008928B, DYK1009313N, DYK1012728B1,
DYK1015727M, DYK1016104N1, DYK1016104N2, DYK1017141M,
DYK1017509C1, DYK1017509C2, DYK1018533B1, DYK1020236B,
DYK1022190P, DYK1022483O1, DYK1066524A, DYK1067380B,
DYK1084936B2, DYK1084936B3, DYK1092442N1, DYK1098495B,
DYK1178464B, DYK1178464B1, DYK1186108B, DYKD1000863N,
DYKD1001089P, DYKD1002116P, DYKD1002212BB, DYKD1002402A,
DYKD1002P, DYKD1002PD, DYKD1003938N, DYKD1004438P,
DYKD1005268A, DYKD1005268A1, DYKD1005417B, DYKD1005457B,
DYKD1005457B1, DYKD1005478B2, DYKD1005489B,
DYKD1005500P, DYKD1005532P, DYKD1005577B, DYKD1005679B,
DYKD1005852A, DYKD1005941B, DYKD1005972B, DYKD1005972B1,
DYKD1005972P, DYKD1006085B, DYKD1006230B, DYKD1006230M,
DYKD1006230M1, DYKD1006272B, DYKD1006789N, DYKD1006854M,
DYKD1006881A, DYKD1006948B, DYKD1006948I, DYKD1007059B,
DYKD1007223A, DYKD1007223A1, DYKD1008186M, DYKD1008663A,
DYKD1008786B, DYKD1008829P, DYKD1009018P, DYKD1009313N2,
DYKD1011059P, DYKD1011867B, DYKD1011867B1, DYKD1011888B,
DYKD1011944BC, DYKD1012359I, DYKD1012359I1,
DYKD1012359P, DYKD1012380I, DYKD1012612B, DYKD1012728B,
DYKD1012918B, DYKD1015787NB, DYKD1015787P, DYKD1015811M,
DYKD1016104N, DYKD1016839B, DYKD1017074N, DYKD1017074N1,
DYKD1017074P, DYKD1017407T, DYKD1017518MB, DYKD1017518P,
DYKD1017582B, DYKD1018497P, DYKD1018505N, DYKD1018505P3,
DYKD1018505P4, DYKD1018525B, DYKD1018533B, DYKD1018660P,
DYKD1019082B2, DYKD1019365B, DYKD1019365B1,
DYKD1019412A, DYKD1019412A1, DYKD1019412P, DYKD1019478B,
DYKD1019478B1, DYKD1019580B, DYKD1019580B1,
DYKD1019783B, DYKD1019890P, DYKD1019922B1, DYKD1019933B,
DYKD1021834N1, DYKD1021850M, DYKD1021850M1,
DYKD1022368B, DYKD1022400P, DYKD1022483O, DYKD1023231P1,
DYKD1023471M, DYKD1023513N, DYKD1023674B, DYKD1023682N,
DYKD1023682N1, DYKD1023682N2, DYKD1023797OB,
DYKD1023807S, DYKD1025011C, DYKD1034163N, DYKD1039911P,
DYKD1041379B2, DYKD1041605B1, DYKD1041605B2,
DYKD1046316P, DYKD1055671N, DYKD1055671N1,
DYKD1055671NN, DYKD1064917I, DYKD1065221BC,
DYKD1066577N, DYKD1066599B, DYKD1066599B1, DYKD1067383B,
DYKD1067387N, DYKD1067387P, DYKD1071777A, DYKD1084936B1,
DYKD1087914A, DYKD1088651B, DYKD1161683B, DYKD1166040N,
DYKD11685B1, DYKD13681M, DYKD14142B, DYKD15084A,
DYKD151491B1, DYKD151747B2, DYKD151989B, DYKD152262IC1,
DYKD152262IC2, DYKD152262TT3, DYKD15262B, DYKD15278ICCU,
DYKD15355P1, DYKD15968B, DYKD16051B, DYKD19605P,
DYKD22234N, DYKD35385P, DYKD4238M, DYKD44742BC,
DYKD48003M, DYKD492446P, DYKD50064C, DYKD55258B1,
DYKD5918IC, DYKD704050BX1, DYKD714050B, DYKD821435OB,
DYKDBABYBOY, DYKDBABYGIRL, DYKDN1008523B, DYKDN1085549N,
DYKDN1092442N, DYKN1006838N, DYKN1006838N1,
DYKN1008593B, DYKN1012165N, DYKN1012307B, DYKN1015466N,
DYKN1084936B, DYKN1084936B1, DYKN1153020B
The following kit reorder numbers contain 4 oz.
bottles of baby lotion: DYK1002998A, DYK1008440A,
DYK1008440A1, DYK1012713M, DYK1017369L2, DYK1017369L3,
DYK1018505M, DYK1023735N5, DYK1066649N, DYK1066649N1,
DYK1079670A1, DYKD1002734A, DYKD1003120A, DYKD1007024M,
DYKD1007031A, DYKD1008488B, DYKD1008881A, DYKD1008958N,
DYKD1008958N1, DYKD1011404A, DYKD1011865B,
DYKD1017369L1, DYKD1017369LD, DYKD1018179P,
DYKD1018505I, DYKD1018505P2, DYKD1018514N,
DYKD1018542N, DYKD1018542N1, DYKD1019290A,
DYKD1019927B, DYKD1020287P, DYKD1020376P,
DYKD1021345B1, DYKD1022BW, DYKD1023735N1,
DYKD1023735N2, DYKD1023735N3, DYKD1023735N4,
DYKD1023797M1, DYKD1029707M, DYKD1041489A,
DYKD1074113N, DYKD1157463A, DYKD15278P,
DYKD19116N, DYKD29012A, DYKD31019B, DYKD60197B,
DYKD63072B, DYKN1007031A, DYKN1012025L,
DYKN1069704N, DYKN1079670A, MSC095018HH;
b) All bottle lots beginning with a "3" or 4001,
4002, 4003, 4004, 4005, 4006, 4007, 4008,
or have no lot number. The following kit reorder
numbers contain 2 oz. bottles of lotion:
DYK1000867P, DYK1001299A, DYK1001875A,
DYK1001908A, DYK1002261A, DYK1002590M,
DYK1002961A1, DYK1002985A, DYK1002985M,
DYK1003157A1, DYK1003157A2, DYK1003157A3,
DYK1004133A3, DYK1004147A1, DYK1004191A,
DYK1004214A, DYK1004385H, DYK1004385K,
DYK1004427A, DYK1004980A3, DYK1004980A4,
DYK1005385A3, DYK1005386A3, DYK1005386A4,
DYK1005386P2, DYK1005395A, DYK1005395A1,
DYK1005679A, DYK1005959AM, DYK1005961A1,
DYK1006209A, DYK1006272A1, DYK1008104A,
DYK1008179A, DYK1008179B, DYK1008179B1,
DYK1008414A1, DYK1008523A1, DYK1008617A,
DYK1009304A1, DYK1009305A1, DYK1009319A3,
DYK1009319A4, DYK1009319A5, DYK1010766M1,
DYK1010872A3, DYK1011669A1, DYK1011734A1,
DYK1011927A, DYK1012070B1, DYK1012094A,
DYK1012094A1, DYK1012713A1, DYK1013004A,
DYK1013004A1, DYK1013004A2, DYK1013004A3,
DYK1013004A4, DYK1013207A1, DYK1013207A2,
DYK1013208A1, DYK1013540A, DYK1013540A1,
DYK1014053A, DYK1014167A, DYK1015831I1,
DYK1016700A1, DYK1017001A1, DYK1017001A2,
DYK1017001A3, DYK1017141M, DYK1017177A1,
DYK1017369L2, DYK1017369L3, DYK1017369S,
DYK1017479A4, DYK1017484A, DYK1017549A3,
DYK1017718A, DYK1018143A, DYK1018179A,
DYK1018179A1, DYK1018563A, DYK1018645A,
DYK1019116A, DYK1019116X, DYK1021280V,
DYK1021323Y1, DYK1021338P, DYK1022117N2,
DYK1022400A, DYK1022594A, DYK1022594A1,
DYK1022941M5, DYK1023776A1, DYK1024854A,
DYK1034111A1, DYK1040238A, DYK1045359M1,
DYK1046608A, DYK1059826A2, DYK1059995A,
DYK1059995A1, DYK1066514A5, DYK1066515A,
DYK1066550A, DYK1066563A, DYK1066649A,
DYK1067383A, DYK1067383A1, DYK1067387P,
DYK1067410P, DYK1067700M7, DYK1067700M8,
DYK1069880A, DYK1082407A1, DYK1088535A,
DYK1088658A, DYK1092717A, DYK1101090A1,
DYK1101090A2, DYK1165070A, DYK1165686K1,
DYK1174835A, DYK1175962A, DYK1176964A,
DYK1176964A1, DYK1185811A, DYK1188783A,
DYK1191170A1, DYK1194889A, DYK1207466A,
DYK50126A2, DYKD1000849AM, DYKD1000909A,
DYKD1000957A, DYKD1001038H, DYKD1001134A,
DYKD1001183A, DYKD1001191A, DYKD1001457A,
DYKD1001457M, DYKD1001457M1, DYKD1001615A,
DYKD1001847T, DYKD1001906A, DYKD1002,
DYKD1002133A, DYKD1002133A1, DYKD1002140A,
DYKD1002141A, DYKD1002150A, DYKD1002165A,
DYKD1002172A1, DYKD1002257A, DYKD1002259A,
DYKD1002295A, DYKD10022A, DYKD1002355A,
DYKD1002401A, DYKD1002437A, DYKD1002463A,
DYKD1002656A, DYKD1002656A1, DYKD1002705A,
DYKD1002705A1, DYKD1002718A, DYKD10028M1,
DYKD1003157A, DYKD1004133A, DYKD1004133A2,
DYKD1004147A, DYKD1004158A, DYKD1004190S,
DYKD1004239A, DYKD1004280M, DYKD1004509P,
DYKD1004633M, DYKD1004633M1, DYKD1005216A,
DYKD1005384A, DYKD1005386A1, DYKD1005386A2,
DYKD1005386P1, DYKD1005388H, DYKD1005400A,
DYKD1005419A, DYKD1005419A1, DYKD1005431A,
DYKD1005435A, DYKD1005500A, DYKD1005500M,
DYKD1005532A, DYKD1005534B, DYKD1005549A,
DYKD1005688A, DYKD1005914P, DYKD1005941A,
DYKD1005961A, DYKD1005961D, DYKD1005972A,
DYKD1005972Y, DYKD1005972Y1, DYKD1006108A,
DYKD1006195A2, DYKD1006211M, DYKD1006272A,
DYKD1006558A, DYKD1006558P, DYKD1006766A2,
DYKD1006841A, DYKD1006841A1, DYKD1006905A1,
DYKD1006905A2, DYKD1006948P, DYKD1006954A,
DYKD1006989A, DYKD1007145A, DYKD1007876A,
DYKD1007876P, DYKD1007893A, DYKD1007893A1,
DYKD1007990P, DYKD1008000A, DYKD1008011A,
DYKD1008182A, DYKD1008829A, DYKD1008869A,
DYKD1008923A, DYKD1008978A1, DYKD1008978A2,
DYKD1009010A, DYKD1009237A, DYKD1009261A,
DYKD1009292A, DYKD1009292A1, DYKD1009301H,
DYKD1009302A, DYKD1009305A, DYKD1009312A,
DYKD1009315A, DYKD1009319A, DYKD1009319A1,
DYKD1009319A2, DYKD1009326A, DYKD1009584A,
DYKD1009709A, DYKD1009709M, DYKD100COLP3,
DYKD100COLP4, DYKD1010372A, DYKD1010731A,
DYKD1010731A1, DYKD1010751A, DYKD1010766A,
DYKD1010766A1, DYKD1010766M, DYKD1010855A,
DYKD1011054OB, DYKD1011438A, DYKD1011555A,
DYKD1011594A1, DYKD1011669A, DYKD1011857A,
DYKD1011946A, DYKD1011946A2, DYKD1011946A3,
DYKD1012070B, DYKD1012238P, DYKD1012288MH,
DYKD1012288P, DYKD1012291A, DYKD1012308A,
DYKD1012308A1, DYKD1012341A, DYKD1012341A1,
DYKD1012480A, DYKD1012612L1, DYKD1012713A,
DYKD1012735A, DYKD1012738A, DYKD1012918A,
DYKD1013192A, DYKD1013207A, DYKD1013214A,
DYKD1013275A2, DYKD1013541A, DYKD1013541A1,
DYKD1013579A, DYKD1013659A, DYKD1014173A1,
DYKD1014185B1, DYKD1014781A, DYKD1014781A1,
DYKD1014997Y, DYKD1015016A, DYKD1015045A,
DYKD1015051A, DYKD1015051P, DYKD1015127A,
DYKD1015127A1, DYKD1015650A, DYKD1015650M,
DYKD1015661A1, DYKD1015661M, DYKD1015711A,
DYKD1015795A, DYKD1015831I, DYKD1015887A,
DYKD1015887A1, DYKD1015898A, DYKD1016465A,
DYKD1016555A, DYKD1016580A1, DYKD1016700A,
DYKD1017001A, DYKD1017074A, DYKD1017177A,
DYKD1017369A, DYKD1017369L1, DYKD1017369LD,
DYKD1017407A, DYKD1017407I, DYKD1017489A1,
DYKD1017489A2, DYKD1017493N, DYKD1017550A,
DYKD1017582A2, DYKD1017681A, DYKD1017783A,
DYKD1018497A, DYKD1018497G, DYKD1018497G1,
DYKD1018512B, DYKD1018512B1, DYKD1018513A,
DYKD1018562A, DYKD1018563A1, DYKD1018578A,
DYKD1018578A1, DYKD1018595D, DYKD1018595M,
DYKD1018595O, DYKD1018663AK, DYKD1019004A,
DYKD1019249A, DYKD1019286A, DYKD1019455P,
DYKD1019558A, DYKD1019580AM, DYKD1019580M1,
DYKD1019743A, DYKD1020287A, DYKD1020325A,
DYKD1020633A, DYKD1021267H, DYKD1021268A,
DYKD1021310P, DYKD1021310P1, DYKD1021311A,
DYKD1021323A, DYKD1021323A1, DYKD1021323A2,
DYKD1021323A3, DYKD1021323P, DYKD1021323P1,
DYKD1021323P2, DYKD1021323P3, DYKD1021323Y,
DYKD1021323Y1, DYKD1021323Y2, DYKD1021366A,
DYKD1021642A, DYKD10216442A, DYKD1021850A,
DYKD1021850M, DYKD1021850M1, DYKD1021856A,
DYKD1021856M, DYKD1021856M1, DYKD1021856M2,
DYKD1021865A, DYKD1021901A, DYKD1022012A,
DYKD1022012A1, DYKD1022012M, DYKD1022012M1,
DYKD1022012M2, DYKD1022109A1, DYKD1022109A2,
DYKD1022117N, DYKD1022117N1, DYKD1022117P,
DYKD1022208A, DYKD1022208A1, DYKD1022665A,
DYKD1022941A, DYKD1022941A1, DYKD1022941M,
DYKD1022941M1, DYKD1022941M2, DYKD1022941M3,
DYKD1022941M4, DYKD1023036P, DYKD1023131A1,
DYKD1023151A1, DYKD1023188A, DYKD1023482A,
DYKD1023550L, DYKD1023550L1, DYKD1023550PC,
DYKD1023577A, DYKD1023674A, DYKD1023707A,
DYKD1023726A, DYKD1023733A, DYKD1023748A,
DYKD1023766AE, DYKD1023776A, DYKD1023786A,
DYKD1023790A, DYKD1023807A, DYKD1025559A,
DYKD1027534A, DYKD1028186A, DYKD1029707A,
DYKD1034131A, DYKD1039892A, DYKD1039911A,
DYKD1039921A, DYKD1040105A, DYKD1041379A1,
DYKD1041385A, DYKD1041862A, DYKD1044791A,
DYKD1049313A, DYKD1057399C, DYKD1058359A,
DYKD1058359A1, DYKD1058363A, DYKD1058367A,
DYKD1059698A1, DYKD1059826A, DYKD1059826A1,
DYKD1062839M, DYKD1062839W, DYKD1064283A,
DYKD1064364A, DYKD1064634A, DYKD1064917A,
DYKD1065425A, DYKD1065545A, DYKD1065545M,
DYKD1065545M1, DYKD1066509A, DYKD1066514A,
DYKD1066514A1, DYKD1066514A2, DYKD1066514A3,
DYKD1066514A4, DYKD1066577A1, DYKD1066618A,
DYKD1066618A1, DYKD1066705A, DYKD1066A,
DYKD1067282A, DYKD1067282A1, DYKD1067380A,
DYKD1067380A1, DYKD1067381A, DYKD1067387A,
DYKD1067387A1, DYKD1067700M5, DYKD1067700M6,
DYKD1067959A, DYKD1070075A, DYKD1070118A,
DYKD1070118T, DYKD1071574A, DYKD1072153A,
DYKD1072227A, DYKD1073231P, DYKD1074113N,
DYKD1075210M, DYKD1075210M1, DYKD1075210M2,
DYKD1075641A, DYKD1077047A, DYKD1078243A,
DYKD1078899A, DYKD1078899A1, DYKD1081924A,
DYKD1082407A, DYKD1082407M, DYKD1082407M2,
DYKD1084108M, DYKD1084108M1, DYKD1084108M2,
DYKD1084144A1, DYKD1086294A, DYKD1086294M,
DYKD1089881A, DYKD11002A3, DYKD1101090A,
DYKD11081A, DYKD1150603A, DYKD1151108T,
DYKD1154308A, DYKD1154308A1, DYKD1154643A,
DYKD1165686C, DYKD1168572A, DYKD1175041A, DYKD1186A,
DYKD124357A1, DYKD139027A, DYKD14109A, DYKD14152A,
DYKD14320A, DYKD14320P, DYKD151105A, DYKD151194A,
DYKD151198A, DYKD151216A, DYKD151301A, DYKD151592A,
DYKD152262A2, DYKD15262A, DYKD15278A, DYKD15498A1,
DYKD15750A, DYKD16393A, DYKD17507MS1, DYKD19138A,
DYKD2004AD, DYKD2004BD, DYKD21139A, DYKD21630A,
DYKD22087AM, DYKD23083A, DYKD23093P, DYKD23141A,
DYKD23153A, DYKD25832A, DYKD26747A1, DYKD27788A,
DYKD32643P, DYKD39021M, DYKD4082M, DYKD43362A,
DYKD43557A3, DYKD44074A, DYKD44075A, DYKD44205A,
DYKD46334A, DYKD46437A, DYKD49572A, DYKD4970A1,
DYKD49892A2, DYKD50019A3, DYKD500318A, DYKD500318AX1,
DYKD50126A, DYKD50176A1, DYKD50620A, DYKD5081A,
DYKD5086A, DYKD51325A1, DYKD5241A, DYKD53043A,
DYKD53191A, DYKD53191P, DYKD54833A1, DYKD5539A,
DYKD5825A, DYKD5891A1, DYKD612A, DYKD61526A,
DYKD61599A, DYKD61682A, DYKD739102A, DYKD743415A,
DYKD751468A2, DYKD762320P, DYKD780210J, DYKD828200A,
DYKD90814OP, DYKD91272AD, DYKDG695A, DYKDG695A2,
DYKDN1008523A, DYKDN1011060A, DYKDN1011734A,
DYKDN1013307A, DYKDN1063571A, DYKDN1085549A,
DYKN1004256A1, DYKN1005518F1, DYKN1005386A,
DYKN1005386P, DYKN1005518M1, DYKN1005518M2,
DYKN10055386A, DYKN1006159A, DYKN1008064A,
DYKN1008608P, DYKN1009314A, DYKN1011012C,
DYKN1011012V, DYKN1011679M, DYKN1011734BP,
DYKN1012165M, DYKN1012171A, DYKN1014293A, DYKN1014293A1,
DYKN1014971A, DYKN1015466A, DYKN1016569A, DYKN1016569A1,
DYKN1019004A, DYKN1019004A1, DYKN1019004P,
DYKN1019004P1, DYKN1021944A, DYKN1022200P, DYKN1022384P,
DYKN1034134A, DYKN1040955M, DYKN1040955N, DYKN1040955N1,
DYKN1055656A, DYKN1064827A, DYKN1069704A, DYKN1069704A1,
DYKNPU1 and MSC095001H.

The following kit reorder numbers contain 4 oz. bottles of lotion: DKY1172636A,
DYK1001650A1, DYK1001793A1, DYK1002287A, DYK1003138A1,
DYK1003944A, DYK1006383A, DYK1007893A3, DYK1007893A4,
DYK1007893A5, DYK1008064A1, DYK1008104A1, DYK1008847A1,
DYK1009304A, DYK1009904A, DYK1010581A, DYK1011034A,
DYK1011495A, DYK1011593A, DYK1011606A, DYK1011891A1,
DYK1011891M, DYK1011945B1, DYK1012026A, DYK1012119A,
DYK1012183P1, DYK1012232A1, DYK1012422H1, DYK1013275A3,
DYK1014493A, DYK1015258A, DYK1015258A1, DYK1015595A,
DYK1015836A, DYK1015836M, DYK1016989M, DYK1017582A3,
DYK1018503A, DYK1018514A, DYK1018533A1, DYK1019292A,
DYK1021652A, DYK1022117A1, DYK1022197A, DYK1022591A,
DYK1022591A1, DYK1023735A1, DYK1029682A, DYK1034130A,
DYK1040139A2, DYK1040139A3, DYK1040139A4, DYK1044978P1,
DYK1047595A, DYK1057519A, DYK1057519G, DYK1062678H,
DYK1065831A1, DYK1066128A, DYK1066646A, DYK1066646A1,
DYK1066658A, DYK1066666A, DYK1069400M, DYK1073114A,
DYK1077038A, DYK1077038A1, DYK1077257A, DYK1082600A,
DYK1088656A, DYK1090570W, DYK1100748A, DYK11199A2,
DYK1150235A, DYK1160184M, DYK1166218A, DYK1171804A1,
DYK1172636A, DYK1177716A, DYK1183936A, DYK1194815A,
DYKD1000841A, DYKD1000858A, DYKD1000907A, DYKD1000923A,
DYKD1001437A, DYKD1001650A, DYKD1001695A, DYKD1001793A,
DYKD1001808A, DYKD1001808A1, DYKD1001899M, DYKD1001A,
DYKD1002169T, DYKD1002348A, DYKD1002373A, DYKD1002375A,
DYKD1002907A, DYKD1002907A1, DYKD1002986M, DYKD1002A,
DYKD10030070A, DYKD1003070A, DYKD1003094, DYKD1003094A,
DYKD1003212A, DYKD1003632A, DYKD1003928G, DYKD1003938A,
DYKD1003938C, DYKD1003996A, DYKD1004094A, DYKD1004206F,
DYKD1004206M, DYKD1004212A, DYKD1004458A, DYKD1004506A,
DYKD1004577A, DYKD1004946A, DYKD1005411A, DYKD1005472A,
DYKD1005474A, DYKD1005478P, DYKD1005483A, DYKD1005941P,
DYKD1006085A1, DYKD1006110A, DYKD1006200A,
DYKD1006230A1, DYKD1006230M, DYKD1006372A, DYKD1006789M,
DYKD1006989P1, DYKD1007893A2, DYKD1008367A,
DYKD1008403A, DYKD1008744A, DYKD1008771A, DYKD1008817A,
DYKD1008830A, DYKD1008847A, DYKD1008852A, DYKD1008929A,
DYKD1008988A, DYKD1008988A1, DYKD1008988A2,
DYKD1008993A, DYKD1008993A1, DYKD1009018A,
DYKD1009018A1, DYKD1009081A, DYKD1009223A, DYKD1009309A,
DYKD1009309A1, DYKD1010115A, DYKD1010404C,
DYKD1010986P1, DYKD1011014A, DYKD1011054A, DYKD1011059A,
DYKD1011136F, DYKD1011136M, DYKD1011563M, DYKD1011563M1,
DYKD1011585A, DYKD1011671A, DYKD1011726A, DYKD1011885A,
DYKD1011909A, DYKD1011935A, DYKD1011945B, DYKD1012057A,
DYKD1012095A, DYKD1012163A, DYKD1012163A1, DYKD1012183P,
DYKD1012232A, DYKD1012288A, DYKD1012422H, DYKD1012726A,
DYKD1012728P, DYKD1013765A, DYKD1013770A, DYKD1014057A,
DYKD1014477A, DYKD1014534D1, DYKD1014894A2,
DYKD1014985A, DYKD1015077A, DYKD1015233A, DYKD1015595A2,
DYKD1015791B, DYKD1016104A, DYKD1016104A1, DYKD1016164M,
DYKD1016165A, DYKD1016469A, DYKD1017104M, DYKD1017362A,
DYKD1017362A1, DYKD1017362A2, DYKD1017488A,
DYKD1017488A1, DYKD1017493A, DYKD1017502A, DYKD1017518A,
DYKD1017922A, DYKD1017922A1, DYKD1018205A,
DYKD1018205A1, DYKD1018533A, DYKD1018541A,
DYKD1018541A1, DYKD1018542A, DYKD1018568A, DYKD1018585A,
DYKD1018732A, DYKD1018992A, DYKD1019268A, DYKD1019890A,
DYKD1020631A, DYKD1020880A, DYKD1021268P4,
DYKD1021278M, DYKD1021411A, DYKD1021834A,
DYKD1022207A1, DYKD1022117A, DYKD1022207M,
DYKD1022211A, DYKD1022397A, DYKD1022440A,
DYKD1022486A, DYKD1022486A1, DYKD1022597A, DYKD1022610A,
DYKD1022643P, DYKD1022868A, DYKD1023535M1,
DYKD1023550L, DYKD1023560P, DYKD1023658A1,
DYKD1028626A, DYKD1035A, DYKD1040139A,
DYKD1040139A1, DYKD1044978P, DYKD1045425A,
DYKD1045457A, DYKD1045954A, DYKD1046741A1,
DYKD1047792A, DYKD10513A, DYKD10513I, DYKD1051400M,
DYKD1055671A, DYKD1057519A, DYKD1058363A1,
DYKD1059923A, DYKD1062084A, DYKD1062861A, DYKD1064832A,
DYKD1065503A, DYKD1065831A, DYKD1066473A,
DYKD1066637PY, DYKD1067490A, DYKD1067490A1,
DYKD1069268A, DYKD1069439A, DYKD1069585A,
DYKD1081765D, DYKD1081765P, DYKD1083475A, DYKD1084904A,
DYKD10914A, DYKD1094391A, DYKD11199A1, DYKD1157310A,
DYKD1157310A1, DYKD1159847M, DYKD11623A, DYKD1165052A,
DYKD11685A, DYKD1171804A, DYKD12311A1, DYKD14135AX,
DYKD14169A1, DYKD14184A, DYKD14613A1, DYKD151317A,
DYKD152249H, DYKD15278PSY, DYKD15630A1, DYKD15792A,
DYKD162S1, DYKD17190A1, DYKD21124A, DYKD21366A1,
DYKD22038A, DYKD23290A, DYKD2540A, DYKD29085A,
DYKD29395A, DYKD3009AP1, DYKD31095A, DYKD31453A,
DYKD32847A, DYKD33118A1, DYKD33160A1, DYKD406281A,
DYKD41512A1, DYKD42378A, DYKD43240A1, DYKD43387A2,
DYKD44302A2, DYKD494806A, DYKD500318AX, DYKD5048A,
DYKD520276A, DYKD53139A, DYKD5627A, DYKD56443A,
DYKD57117M, DYKD58922A, DYKD61586B, DYKD63249A,
DYKD64737A, DYKD64737AM, DYKD6719A, DYKD711091AX,
DYKD712608A1, DYKD712608A2, DYKD715748A, DYKD715990A,
DYKD7263A1, DYKD7323A, DYKD744274A, DYKD748223P,
DYKD753049AX1, DYKD805002A, DYKD832499A, DYKD90814A,
DYKG1407A, DYKN1000883A, DYKN1000927A, DYKN1001450A,
DYKN1005518S, DYKN1005518S1, DYKN1007881A,
DYKN1007881A1, DYKN1008608A, DYKN1010991A, DYKN1011935A,
DYKN1012025A, DYKN1012379A, DYKN1013490A, DYKN1013493A,
DYKN1016652A, DYKN1020908A, DYKN1034127A, DYKN1044932I,
DYKN1044978P, DYKN1066481A, DYKN1070589A, DYKN1070589A1,
DYKN1070841A, DYKN1078288A, DYKN1097943A
and MSC095004H;
c) All bottle lots beginning with a "3" or 4001,
4002, 4003, 4004, 4005, 4006, 4007, 4008,
or have no lot number. The following kit reorder
numbers contain the 3.5 oz bottles: DYKD1013275A2,
MSC090472H and MSC090474H;
d) All bottle lots beginning with a "3" or 4001,
4002, 4003, 4004, 4005, 4006, 4007, 4008, or
have no lot number. The following kit reorder
numbers contain 2 oz. bottles of baby oil:
DYK1004385B, DYK10223668B, DYK1022368B,
DYK1082407I1, DYKD1005919B2, DYKD1006195N1,
DYKD1006948B, DYKD1011944BC, DYKD1021267H,
DYKD1022BW, DYKD1070118I, DYKD1082407I,
DYKD1166040N, DYKN1015466N, DYK1005919B3 and
DYK1022368B1

The following kit reorder numbers
contain 4 oz. bottles of baby oil: DYKD1023674B,
DYKD1034163N, DYKD1046741A, DYKD1046741A1,
DYKD1074113N, DYKD1084904A, DYKD1087914A,
DYKD15278P, DYKD39254B1, DYKD55021B and MSC095052H.

RECALLING FIRM/MANUFACTURER Medline Industries, Inc., Mundelein, IL, by letters dated March 29, 2004. Firm initiated recall is complete.
REASON Lotions and oils are contaminated with Burkholderia cepacia, and fungus respectively.
VOLUME OF PRODUCT IN COMMERCE 2,443,750 bottles, 1,461,300 kits.
DISTRIBUTION Nationwide and Internationally.

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March 23, 2005 Starbrite brand Black Magic Color Tattoo Ink -2005
PRODUCT Tattoo Ink: Starbrite brand Black Magic Color, packaged in individual 1û2 oz., 1 oz., 2 oz., 4 oz. and 8 oz. size translucent plastic bottles. Each bottle bears a paper label reading in part: "Starbrite Colors™ BLACK MAGIC pure uncut pigment dispersion XXX Ingredients: Alcohol, Distilled, Water, glycerin, Color #213BM XXX Date Produced: XXX Best if Use By: 2oz Made In The USA XXX". Recall # F-213-5.
CODE 7996988 and 7996989
RECALLING FIRM/MANUFACTURER Papillon Supply & Manufacturing, Enfield, CT, by telephone on or about June 25, 2004. Firm initiated recall is complete.
REASON The product is contaminated with Acremonium mold and Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE 500 gallons
DISTRIBUTION Nationwide and Scotland

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March 23, 2005 Premier True Color Pigments in 0.5 oz containers -2005
PRODUCT Premier True Color Pigments in 0.5oz containers including the following shades: Areola Highlighter; Light Pink Areola; Pink Areola; Dark Pink Areola; Light Natural Areola; Natural Areola; Dark Natural Areola; Light Brown Areola; Brown Areola; Dark Brown Areola; Light Ebony Areola; Ebony Areola; Dark Ebony Areola; Sheer Bronze; Bliss; Cherry Cheek; Half Naked; Peach Glow; Dark Taupe Shadow; Taupe Mist; Taupe Halo; Taupe Smudge; Antique Pink; Cherry Red; Spiced Cider; Hot Fuchsia; Blush; Hot Coral; Peaches and Crème; Pink Passion; Poetic Wine; Dark Brown Crème; Brown Crème; Tropical Passion; Electric Plum; Cherrywood; Indian Summer; Chestnut; Dark Pecan; Black Fudge; Light Brown Crème; Scarlet; Black Velvet; Wheat; Ash; Khaki Crème; Baby Blue; Purple Slate; Electric Blue; Rich Raspberry; Violet Smoke; Dark Cherry Red; Crimson; Autumn Sunset; Spiced Nude; Dark Chestnut; Light Wheat;
Electric Violet; Dark Wheat; Light Sandalwood; Dark Sandalwood; Cognac; Light Brown Suede; Chocolate Spice; Dark Smoke; Chocolate Mauve; Double Fudge; Black Suede; Double Dark Fudge; Chocolate Raspberry; Chocolate Kiss; Rosewood; Mochaccino; Plum; Flaming Red; Dark Brown; Suede; Copper Kiss; Black Chestnut; Double Black Fudge; Indigo Teal; Toasted Smoke; Bright Blue; Cobalt Blue; Emerald Green; Iced Spice; Blue Slate; Mocha Mauve; Dark Autumn; Autumn; Light Autumn; Warm Blonde; Chocolate Cinnamon; Dusty Rose; Chocolate Ruby; Dark Champagne; Champagne; Light Champagne; Dark Ash; Ash; Light Ash; Caramel; Light Caramel; Mahogany; Cotton Candy; Spice; Electric Fuchsia; Warm Blush; Spiced Melon; Evergreen; Sandalwood; Light Pecan; Pecan; Sage; Chocolate Orchid; Purple Passion; Teal; Dark Fudge; Black Brown Suede; Fudge; Black Slate; Babies Breathe; Burgundy Wine; Candied Raisin; Rich Russet; Blue Bonnet; Double Black Magic; Soft Smoke; Coffee Bean; Naturally Nude; Electric Orchid; Chocolate Grape; Toasted Almond; Rustic Rose; Sienna; Brown Suede; Cool Blonde; Blonde Taupe; Umber; Dark Umber; Black Umber; Beautiful Brown; Lip Highlighter; Dark Brown Sugar; Toasted Taupe; Black Magic; Dark Caramel; Light Porcelain; Porcelain; Buff; Ivory Crème; Shell; Light Beige Crème; Beige Creme; Dark Beige Creme; Cool Beige; Dark Cool Beige; Light Suntan; Suntan; Dark Suntan; Light Bronzing Crème; Bronzing Crème; Dark Bronzing Crème; Honey Bisque; Dark Honey; Bisque; Honey Brown; Chocolate Honey; Dark Chocolate; White Linen; Tangerine; Lemon Crème; True Red; Orange Crème; Black to Brown Eyeliner Corrector; Blue to Black/Brown Corrector; Orange/Peach Eyebrow Corrector; Purple Lip Corrector; Gray/Ash Eyebrow Corrector; Green Eyebrow Corrector; Blue Lip Corrector; Purple Eyebrow Corrector; Pink Eyebrow Corrector; Blue Eyebrow Corrector. Recall # F-222-5.
CODE All Lots.
RECALLING FIRM/MANUFACTURER American Institute of Intradermal Cosmetics, Arlington, TX, by letters dated July 7, 2003 and August 30, 2004. Firm initiated recall is ongoing.
REASON The pigments have not been approved for their intended use of tattooing and have been associated with adverse reactions that include swelling, cracking, peeling, blistering, and scarring as well as formation of granulomas (chronically inflamed tissue mass associated with an infection) in the areas of the eyes and lips.
VOLUME OF PRODUCT IN COMMERCE 52,114 containers.
DISTRIBUTION Nationwide and Internationally.

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May 25 , 2005 Design a Face Make-up -2005
PRODUCT Design a Face Make-up. Various configurations that include: Theme Packs; Color Compacts, 6 Color Paint Packs; Body Glitter Gel, Glow in the Dark Paint, Face Paint Stencil, Face Paint Foam Stampers, and Face Paints with Book. Recall # F-384-5.
CODE Item Numbers: (No lots identified) 8900 --Theme Pack - Sports; 8901--Theme Pack - Puppies; 8902--Theme Pack - Kittens; 8903-- Theme Pack - Tiger; 8904--Theme Pack - Clown; 8905 -- Color Compact - White -Clamshell; 8906-- Color Compact - Black -Clamshell; 8907-- Color Compact - Sky Blue -Clamshell; 8908 --Color Compact - Red -Clamshell; 8909 --Color Compact - Green --Clamshell; 8910 --Color Compact - Pink --Clamshell; 8911 --Color Compact - Yellow - Clamshell; 8912 --Color Compact - Orange - Clamshell; 8913 --Color Compact - Brown - Clamshell; 8914 --Color Compact - Purple - Clamshell; 8915 --Color Compact - Navy Blue - Clamshell; 8916 --6 Colors Paint Pack; 8919 --Face Paint Studio - Med. Box; 8920 --Body Glitter Gel; 8921 -- Glow in the Dark Paint; 8922 -- Face Paint Stencil; 8923 --Face Paint Foam Stampers; 8927--Face Paints with Book.
RECALLING FIRM/MANUFACTURER Recalling Firm: Rose Art Industries, Inc., Livingston, NJ, by letter on March 18, 2005.
Manufacturer: Galisa Cosmetics International Corp., Hsintien Taipei Hsien, Taiwan. Firm initiated recall is ongoing.
REASON Face paint products have caused minor adverse reactions in children. Adverse reactions include redness of the skin or a skin rash, irritation, itching or minor swelling in the area where the paints were applied.
VOLUME OF PRODUCT IN COMMERCE 1,629,444 units.
DISTRIBUTION Nationwide

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October 5 , 2005 "Baby Wipe" and Triad "Cleansing Wipes" brands -2005
PRODUCT a) "Baby Wipe" brands come in either scented or unscented
packaged in a flexible plastic container. Labeled in
part: Alcohol-Free Baby Wipes are soft, thick,
convenient wipes moistened with a gentle cleansing
solution that will clean any part of baby's delicate
skin. Sizes: Triad 80 -7.25" x 8, AmeriNet Choice 40 –
7.25" x 8". Product Code: 10-6810, AC-6710, 10-6710,
10-6700, 10-6610 and AC-6700, Recall # F-654-5;
b) Triad "Cleansing Wipes" packaged in a plastic flexible
container. Labeled in part: Triad Cleansing Wipes,
Hypoallergeenic, Unscented, Alcohol-Free, Deodorizing
Formula (40 - 7.25" x 8" Wipes), Product Code: 10-6610,
Recall # F-655-5
CODE a) Lot #'s, 4G80, 4G79, 4H99, 4H83, 4H84, 4J59, 4J61,
4J01, 4J60, 4J55, 4J58, 4K73, 4K76,
4K75, 4K113, 4K74;
b) Lot numbers 4J59, 4J64, 4K73
RECALLING FIRM/MANUFACTURER Recalling Firm: H & P Industries, Inc., Brookfield, WI, by letters dated January 17, 2005 and February 18, 2005.
Manufacturer: H & P Industries, Inc., Pewaukee, WI. Firm initiated recall is ongoing.
REASON Products are contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE 105,348 units
DISTRIBUTION Nationwide

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October 5 , 2005 Cran brand Face Paint, 5 colors -2005
PRODUCT Cran brand Face Paint, 5 colors; UPC 7-08820-45951-9, Made in Taiwan, Recall # F-671-5
CODE All units
RECALLING FIRM/MANUFACTURER Wholesale Merchandisers, Inc., Grand Rapids, MI, by posting a notice in the stores and on the website, on June 17, 2005. Firm initiated recall is complete.
REASON Face paints contain unapproved colors and may have been manufactured under conditions whereby they were contaminated with pathogens.
VOLUME OF PRODUCT IN COMMERCE 38 packages
DISTRIBUTION OH

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OCTOBER 26, 2005 Medication Mardel biospheres Maracide for Ick, Velvet, and other external
Parasites -2005
PRODUCT a) Medication Mardel biospheres Maracide for Ick, Velvet, and other external Parasites, Contents 2 fl. oz. (59mL)
and Fish Care Guide. Virbac Animal Health. Active Ingredients: Malachite green, Chitosan, Recall # V-001-6;
b) Medication Mardel Maroxy for True fungal infections of fish and eggs. Contents 2 fl. oz. (59mL) and Fish Care Guide. Virbac Animal Health. Active Ingredients: Stabilized
chlorine oxides, Recall # V-002-6
CODE a) Lot number: WE433;
b) Lot number: PF422
RECALLING FIRM/MANUFACTURER Virbac AH, Inc., Fort Worth, TX, by telephone and letters on September 14, 2005. Firm initiated recall is ongoing.
REASON Product designed to treat external parasites in fish aquariums was packaged with labeling for another product.
VOLUME OF PRODUCT IN COMMERCE 19,366 units
DISTRIBUTION Nationwide and Canada

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December 28, 2005 Deluxe Dish Detergent Antibacterial Hand Soap -2005
PRODUCT Deluxe Dish Detergent Antibacterial Hand Soap, 50 oz. Recall # D-067-6
CODE Lot numbers: (Manufacturing Dates): Tues-Oct. 11, 2005: 284525AA3, 284525AA4, 284525AA5, 284525AA6; Wed. Oct. 12, 2005: 285525AA1, 285525AA3, 28525AA4; Fri. Feb. 25, 2005: 056530AA1, 056530AA2, 056530AA3, 056530AA4, 056530AA5; Mon. Feb. 26, 2005: 059530AA1, 059530AA2, 059530AA3, 059530AA4, 059530AA5, 059530AA6: Tues. Feb. 27, 2005: 060530AA1, 060530AA2, 060530AA3, 060530AA4, 060530AA6, 060530AA8, 060530AA9 and Wed. Feb. 28, 2005: 061530AA8, 061530AA9
RECALLING FIRM/MANUFACTURER Showline, Raleigh, NC, by letter on/about November 28, 2005. Firm initiated recall is ongoing.
REASON Misbranded: Lack of active ingredient, Triclosan
VOLUME OF PRODUCT IN COMMERCE 13,068 cases
DISTRIBUTION Nationwide

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March 24 , 2004 John Frieda Hair Sprays -2004
PRODUCT Sheer Blond Curvaceous Blonde 6.7 fluid ounces pump spray, sold only at Eckerd stores in the states of Delaware, Maryland, New Jersey, Pennsylvania and Virginia. The Eckerd stores who received the indicated lots have been notified and are pulling the product from their shelves.
CODE The product recall is limited to the following lot codes: S001AW037 and S001AW040. The code is printed on the bottom of the bottle.
RECALLING FIRM/MANUFACTURER Recalling Firm: John Frieda Professional Hair Care, Inc. (toll free hotline at 1-800-521-3189, 8am - 5pm M-F, EST)
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
REASON The voluntary recall was initiated after routine testing revealed a possible contamination with Pseudomonas, a bacterium which can cause infections in an open wound or cut in rare circumstances. The infections are easily treated with antibiotics and usually do not represent a serious health effect.
VOLUME OF PRODUCT IN COMMERCE 104 cases (624 bottles)
DISTRIBUTION Delaware, Maryland, New Jersey, Pennsylvania and Virginia

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June 16 , 2004 Orasept Antiseptic Mouthwash & Gargle -2004
PRODUCT Orasept Antiseptic Mouthwash & Gargle (cetylpyridinium HCl 0.05% w/w), 4 fl. oz. (118 mL) bottles, over-the-counter. NDC 55422-202-04. Recall # D-182-4.
CODE Lot 4B45, Expiration Date 01/06.
RECALLING FIRM/MANUFACTURER Pharmakon Laboratory, Inc., Tampa, FL, by letter on April 19, 2004. Firm initiated recall is ongoing.
REASON Microbial contamination (yeast and mold).
VOLUME OF PRODUCT IN COMMERCE 9,754 bottles.
DISTRIBUTION PA, GA, and CT.

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June 16 , 2004 Colgate Fluoride Toothpaste -2004
PRODUCT a) Colgate Fluoride Toothpaste, Maximum Cavity Protection,
(Sodium Monofluorophosphate 0.76% (1000ppm F) and Sodium
Fluoride 0.1% (450ppm F)), packaged in 100-ml tubes, net
wt. 5 oz., Regular Flavour. Recall # D-186-4.
b) Colgate Fluoride Toothpaste Triple Action, (1.10% Sodium
Monofluorophosphate and 0.20% Triclosan) packaged in
100-ml. tubes, net wt. 5-oz. Recall # D-187-4;
c) Mentadent P, Fluoride Toothpaste, (0.74% Sodium Mono-
Fluorophosphate), packaged in 100-ml. tubes, Net Wt 5
oz. Recall # D-188-4;
d) Colgate Fluoride Toothpaste, Herbal, (1.10% Sodium
Monofluorophosphate, packaged in 100-ml. tubes, NET WT 5
oz. Recall # D-189-4;
e) Aquafresh Fluoride Toothpaste, (Sodium
Monofluorophosphate 0.76% w/w), packaged in 100-ml.
tubes, 5 OZ. Recall # D-190-4.
CODE a) All Lots: South African labeling SKU: 458976;
b) All Lots: South African labeling SKU: 445077;
c) All Lots: South African labeling SKU: 458977;
d) All Lots: South African labeling SKU: 460361;
e) All Lots: South African labeling SKU: 418030.
RECALLING FIRM/MANUFACTURER Deals Nothing Over A Dollar, Earth City, MO, by letters on March 3, 2004 and email on March 11, 2004. Firm initiated recall is complete.
REASON Misbranded; labeling is not in compliance with regulations.
VOLUME OF PRODUCT IN COMMERCE Approximately 50,000 tubes.
DISTRIBUTION Nationwide

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July 2, 2003 Chunkie Face Paints-2003
PRODUCT a) Chunkie Face Paints 4-Pack packed in four plastic
squeezable tube applicator bottles with a cap and a soft brush tip and four different colored tubes (white, red, yellow and blue). Recall # F-407-3;
b) Chunkie Face Paints 4-Pack packed in four plastic
squeezable tube applicator bottles with a cap and a soft brush tip and four different colored tubes (white, red, black and green). Recall # F-408-3.
CODE All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER Recalling Firm: Publix Super Markets, Lakeland, FL,
by e-mail on February 19, 2003.
Manufacturer: Bluepath Industries, LTD, Edmonton, Alberta, Canada. FDA initiated recall is ongoing.
REASON Both products contain D&C Red No. 7, a color that was not approved for use as a cosmetic in close proximity of the eye as shown in the vignette.
VOLUME OF PRODUCT IN COMMERCE 360 cases/6 per case.
DISTRIBUTION FL.

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July 9, 2003  Coppertone Bug & Sun Sunscreen with Insect Repellent, SPF 30, Kid's Formula-2003
PRODUCT a) Coppertone_ Bug & Sun Sunscreen with Insect Repellent,
(N, N-diethyl-m-toluamide 9.5% and other isomers 0.5%),
SPF 30, Kid's Formula, 4 FL OZ (118mL) and 8 FL OZ
(237mL) bottles. Recall # D-271-3;
b) Coppertone_ Bug & Sun Sunscreen with Insect Repellent,
(N,N-diethyl-m-toluamide 9.5% and other isomers 0.5%),
SPF 30, Kid's Formula, 8 FL OZ (237mL) bottles. Recall # D-272-3.
CODE a) 2D01PM, 2P02PM, and 3A01PM;
b) 1J01PM, 1M05PM, 1M01PM, 1M06PM, 1M05PM, 1M05APM,
1M04PM, 1N01PM, 1N06PM, 1N05PM, 1N04PM, 1N03PM,
1N02PM, 2A08PM, 2A04PM, 2A03PM, 2A02PM, 2A01PM,
2D03PM, 2E01PM, 2H01PM, 2J02PM, 2J01PM, 2K03PM,
2K02PM, 2K01PM, 2M01PM, 2N01PM, 2P01PM, 3A04PM,
3A02PM, 3B06PM, 3B01PM, 3B05PM, 3B04PM, 3B03PM,
M312005/3B06PM, M312005A, M312005B, M312105,
3C02PM, 3C01PM, and 3C03PM.
RECALLING FIRM/MANUFACTURER Prime Enterprises, Inc., Miami Lakes, FL, by letters on May 30, 2003.
REASON a) These lots contain trace quantities of an additional
sunscreen, benzophenone-4, which were incorrectly added to
the formulation.
b) Certain lots of product may contain undeclared preservative.
VOLUME OF PRODUCT IN COMMERCE 902,519 units.
DISTRIBUTION Nationwide.

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August 6, 2003   Ray Block Sunscreen Lotion, SPF 15-2003
PRODUCT Ray Block Sunscreen Lotion, (Octyl Dimethyl PABA 5% and Benzophenone 3.3%) SPF 15, 1 FL OZ (29.6mL) and 4 FL OUNCES (118.3 mL). Recall # D-282-3.
CODE Lot D32, expiration date 04/05.
RECALLING FIRM/MANUFACTURER Recalling Firm: Crown Laboratories, Inc., Johnson City, TN, by letters on June 5, 2003.
Manufacturer: DEL-RAY LABS, INC., Birmingham, AL. Firm initiated recall is ongoing.
REASON Superpotent; octyl dimethyl PABA and oxybenzone.
VOLUME OF PRODUCT IN COMMERCE 319-4 oz and 324-1 oz bottles.
DISTRIBUTION Nationwide.

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September 1 , 2004 Clare Burke Lathering Scrubs -2004
PRODUCT a) Clare Burke, Blushing Rose Lathering Scrub, 8 oz.,
Recall # F-370-4;
b) Claire Burke Lathering Scrib, Original Scent, 8 oz.
Recall # F-371-4.
CODE a) Product Codes 08125.041 and 08125.F41;
b) Product Codes 08125.085, 08125F85.
RECALLING FIRM/MANUFACTURER Esscentual Brands Inc, Scottsdale, AZ, by letters on May 20, 2004. Firm initiated recall is ongoing.
REASON Lathering Scrubs have high pH.
VOLUME OF PRODUCT IN COMMERCE Not able to be determined.
DISTRIBUTION Nationwide and Internationally.

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September 1 , 2004 Sebolux Medicated Shampoo for Dogs and Cats & Epi-Otic Ear Cleanser for dogs, cats, puppies, and kittens -2004
PRODUCT a) Sebolux Medicated Shampoo for Dogs and Cats,
Antiseborrheic Keratoplastic, 8 fl. Oz., Active
Ingredients: Solubilized Sulfur (equivalent to 2%
elemental Sulphur) and 2% salicylic acid. Recall #
V-162-4;
b) Epi-Otic Ear Cleanser for dogs, cats, puppies, and
kittens. Cleansing, drying, non-irritating. Recall #
V-163-4.
CODE a) and b) WJ363.
RECALLING FIRM/MANUFACTURER Virbac AH, Inc., Fort Worth, TX, by telephone on July 15, 2004. Firm initiated recall is ongoing.
REASON Bottles labeled at Sebolux Medicated Shampoo for dogs and cats contain EPI-Otic Ear Cleanser for Dogs, Cats, Puppies, and kittens.
VOLUME OF PRODUCT IN COMMERCE 22,824 units.
DISTRIBUTION Nationwide

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September 1 , 2004 C.E.T. Home Dental Care Oral Hygiene Gel for Dogs and Cats-2004
PRODUCT C.E.T. Home Dental Care Oral Hygiene Gel for Dogs and Cats, NDC 051311-502-32, 1.4 fl. Oz. (32 mL). 0.12% Chlorhexidine Gluconate. Recall # V-164-4.
CODE All lots of the product on the market are being recalled . The subpotent lots are WF363, WF313, WH352, WL307, and WC433.
RECALLING FIRM/MANUFACTURER Virbac AH, Inc., Fort Worth, TX, by letter on July 14, 2004. Firm initiated recall is ongoing.
REASON Subpotency.
VOLUME OF PRODUCT IN COMMERCE 88,366 units.
DISTRIBUTION Nationwide

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September 8 , 2004 John Frieda brand Sheer Blonde Curvaceous Blonde Curl-Defining Styler-2004
PRODUCT John Frieda brand Sheer Blonde Curvaceous Blonde Curl-Defining Styler, Curls Swirls Brightens Blond Hair, packaged in 6.7 fl. Oz. plastic bottles with pump sprayer, 6 bottles per case. Item/SKU #7-17226-00502-2; Order No. 0723859. Recall # F-427-4.
CODE Lots: # S001AW037 and #S001AW040.
RECALLING FIRM/MANUFACTURER Andrew Jergens Co, Cincinnati, OH, by email, fax, and letter on March 22, 2004. Firm initiated recall is complete.
REASON The product may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE 104 cases.
DISTRIBUTION PA.

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September 22 , 2004 Pantene PRO-V shampoo (various) -2004
PRODUCT a) Pantene PRO-V shampoo Hydrating Curls, 400 mL (13.5 fl oz.). Shampoo is packaged in a plastic bottle.
UPC 80878-00451. Recall # F-446-4;
b) Pantene PRO-V shampoo Classic Clean, 400 mL (13.5 fl
oz.). Shampoo is packaged in a plastic bottle.
UPC 80878-00452. Recall # F-447-4;
c) Pantene PRO-V shampoo Smooth & Sleek, 400 mL (13.5 fl oz.). Shampoo is packaged in a plastic bottle.
UPC 80878-00448. Recall # F-448-4;
d) Pantene PRO-V shampoo Color Revival, 400 mL (13.5 fl
oz.). Shampoo is packaged in a plastic bottle.
UPC 80878-00449. Recall # F-449-4;
e) Pantene PRO-V shampoo Clarifying, 400 mL (13.5 fl oz.).
Shampoo is packaged in a plastic bottle.
UPC 80878-00453. Recall # F-450-4;
f) Pantene PRO-V shampoo Regular, 400 mL (13.5 fl oz.).
Shampoo is packaged in a plastic bottle. UPC 80878-
00463. Recall # F-451-4.
CODE a) Manufacturer’s code (L) 31345395XD;
b) Manufacturer’s code (L) 31565395XH;
c), d), e) and f) Manufacturer’s code unknown.
RECALLING FIRM/MANUFACTURER APO Health Inc., Oceanside, NY, by letter on August 13, 2004. Firm initiated recall is ongoing.
REASON Products were contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE Approx. 10, 684 cases/12 bottles per case.

DISTRIBUTION NY and OH.

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October 13 , 2004 Breath-eze Breath and Gas Relief Tablets for Dogs-2004
PRODUCT Breath-eze Breath and Gas Relief Tablets for Dogs (activated charcoal, simethicone). Recall # V-186-4.
CODE Lot PJ315.
RECALLING FIRM/MANUFACTURER Virbac AH, Inc., Fort Worth, TX, by telephone on August 26, 2004, and by fax on September 7, 2004. Firm initiated recall is ongoing.
REASON Product contains Breath-eze chewable breath mints which have no active ingredient for gas relief.
VOLUME OF PRODUCT IN COMMERCE 2,100 units.

DISTRIBUTION PA, MA, OH, NJ, AZ, NC, NE, and Canada.

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December 8 , 2004 Top Care® Distilled Extract of Witch Hazel & Top Care® Hydrogen Peroxide Solution -2004
PRODUCT a) Top Care®, Distilled Extract of Witch Hazel, Alcohol 14% by Volume, For Relief of Minor Skin Irritations Due to Insect bites, Minor Cuts and Minor Scrapes, 16 FL OZ (1 PT) 473 mL. The Witch Hazel product is filled in a natural-colored (clear) HDPE bottle. Recall # D-064-5;
b) Top Care®, Hydrogen Peroxide Solution USP, First Aid Antiseptic, For Treatment of Minor Cuts and Abrasions, For use as an Antiseptic Gargle or Rinse, 16FL OZ (1 PT) 473 mL. Hydrogen Peroxide is filled in a brown opaque HDPE bottle to protect it from the damaging effects of light. Recall # D-065-5.
CODE a) and b) Lot #HB1118F.
RECALLING FIRM/MANUFACTURER Aaron Industries, Inc., Lynwood , CA , by telephone and letter on November 16, 2004 . Firm initiated recall is ongoing.
REASON Mislabeling: Witch Hazel product is labeled TopCare® Hydrogen Peroxide, instead of TopCare® Witch Hazel.
VOLUME OF PRODUCT IN COMMERCE 663/16 oz. bottles.


DISTRIBUTION IL.

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December 22 , 2004 John Frieda, Frizz Ease 5-Minute Manager Blow Dryer Styling Spray -2004
PRODUCT John Frieda, Frizz Ease 5-Minute Manager Blow Dryer Styling Spray in 6.7 oz. (200mL) plastic bottle with pump sprayer, packaged 6 bottles per case. Recall # F-106-5.
CODE Lot #S025AS064 ‚ manufactured on 3/4/2004 and Lot #S025AS065 ‚ manufactured on 3/5/2004.
RECALLING FIRM/MANUFACTURER Andrew Jergens Co., Cincinnati, OH, by letter dated August 2, 2004 and by press release on August 12, 2004. Firm initiated recall is ongoing.
REASON Product is contaminated with yeast and mold.
VOLUME OF PRODUCT IN COMMERCE 1,570 cases.
DISTRIBUTION Nationwide

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November 26, 2003  Don't Be Bald Hair Care Treatment, Medicated; BBD 1854 Dandruff Shampoo; and Don't B Bald, Scalp Stimulate-2003
PRODUCT a) DON'T BE BALD Hair Care Treatment, Medicated, "THE
ORIGINAL FORMULAS", Net. Wt. 4 oz. Jars.
Recall # D-065-4;
b) BBD 1854 Dandruff Shampoo, For Professional Use Only,
Anti-Dandruff Conditioning Shampoo, 8 Fl. Oz. bottles (24 Liters). Recall # D-066-4;
c) Don't B Bald, Scalp Stimulate, Organic Formula, 4 Fl. Oz. (118 mL) Jars. Recall # D-067-4.
CODE a) Batch numbers: 55, 64, and 69;
b) Batch number: 10269;
c) Batch numbers: 020800, 53.
RECALLING FIRM/MANUFACTURER Pride and Power, Inc., Houston, TX, by letter on September 30, 2003. FDA initiated recall is ongoing.
REASON Unapproved New Drug.
VOLUME OF PRODUCT IN COMMERCE 5,580 containers.
DISTRIBUTION Nationwide.

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December 10, 2003 The Skin Culture One Day Peeling Treatment and The 6 Day Cosmetic Facial Treatment Kit-2003
PRODUCT a) The Skin Culture One Day Peeling Treatment.
6 Treatments: 6 Cerate 39XXX, 6 Normalizer Applicators,
Jar. Recall # D-024-4;
b) Skin Culture 2 Peeling Treatment, Skin Creams, The 6 Day
Cosmetic Facial Treatment Kit. Recall # D-025-4;
c) Skin Culture 3 Peeling Treatment, Skin Creams. The 6 Day
Cosmetic Facial Treatment Kit. Recall # D-026-4;
d) Skin Culture 4 Peeling Treatment, Skin Creams. The 6 Day
Cosmetic Facial Treatment Kit. Recall # D-027-4.
CODE a) Lots 11132, and 11829;
b) Lot 27652;
c) Lot 28132;
d) Lot 37522.
RECALLING FIRM/MANUFACTURER Skin Culture Institute, Inc., New York, NY, by letter and fax on October 1, and October 2, 2003. FDA initiated recall is ongoing.
REASON Misbranding: Product fails to contain declared ingredient Resorcinol and is subpotent for its sulfur ingredient.
VOLUME OF PRODUCT IN COMMERCE Approximately 4,000 jars.
DISTRIBUTION Nationwide.

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December 10, 2003 Pert Plus, 2 in 1 Dandruff Control Shampoo plus Conditioner-2003
PRODUCT Pert Plus, 2 in 1 Dandruff Control Shampoo plus Conditioner (Pyrithione zinc 1.0%), 13.5 Fl. Oz. (400 mL), 12 bottles per case. Recall # D-071-4.
CODE Lot Numbers: 32765395XA and 32885395XA.
RECALLING FIRM/MANUFACTURER The Proctor & Gamble Company, Cincinnati, OH, by telephone on October 27, 2003. Firm initiated recall is ongoing.
REASON Subpotent for Pyrithione Zinc ingredient.
VOLUME OF PRODUCT IN COMMERCE 1,374 cases.
DISTRIBUTION Nationwide.

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January 16, 2002  Anti-Aging Wrap solution-2002
PRODUCT Anti-Aging Wrap solution, 8 oz., 32 oz. and 36 oz. plastic bottles. (conditioned water plus a proprietary blend of sodium magnesium and potassium salts, boron and other naturally occurring trace elements and herbal essences), Recall # D-070-2.
CODE All Codes labeled as "Anti-Aging Wrap" that were distributed from 10/1/00 through 10/1/01 including lot #'s AA439090500 and AA110101CS.
RECALLING FIRM/MANUFACTURER Recalling Firm: VMM Enterprises, Inc. Clearwater, FL , by letter on Oct. 8, 2001. Manufacturer: Pyramid Consulting and Investiment Co., Inc. Clearwater, FL. FDA initiated recall is ongoing.
REASON Microbial Contamination; product is contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide

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February 27, 2002 Physicians Formula, Eye Makeup Remover Lotion-2002
PRODUCT Physicians Formula, Eye Makeup Remover Lotion, 2 Fl. Oz./ 59 ml., Recall # F-299-2.
CODE Batch Code 0821 and 0601.
RECALLING FIRM/MANUFACTURER Pierre Fabre/Physicians Formula Cosmetics, Azusa, CA, by press release on June 8, 2001 and by fax and letters on June 11, 2001. Firm initiated recall is complete.
REASON The product was contaminated with Pseudomonas fluorescens/putida.
VOLUME OF PRODUCT IN COMMERCE 16,300 units.
DISTRIBUTION Nationwide.

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MARCH 6, 2002 Rejuvenating Mist, manufactured for Soroko Blade Laboratories-2002
PRODUCT Rejuvenating Mist, Manufactured for Soroko Blade Laboratories, Made in Canada. Recall # F-298-2.
CODE All products on the market at the time the recall was initiated (the product was not coded).
RECALLING FIRM/MANUFACTURER Recalling Firm: Soroko Inc., Clifton, NJ, by letters on Jan. 9, 2001. Manufacturer: Elga Laboratories Ltd., Downview, Ontario, Canada. Firm initiated recall is complete.
REASON Rejuvenating Mist was contaminated with Pseudomonas sp.
VOLUME OF PRODUCT IN COMMERCE 250 x 3.3 ounce spray bottles and an undetermined number of 2 oz. bottles.
DISTRIBUTION NY, NJ, TX, Mexico, Scotland and Canada.

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April 17, 2002 HAND MEDIC Antiseptic Skin Treatment-2002
PRODUCT HAND MEDIC Antiseptic Skin Treatment, OTC, packaged in 500 ml cartridges, and 2 oz, 4 oz, and 8 oz bottles. Active ingredient: Benzalkonium Chloride 0.1%. Recall # D-237-2. The 500 ml cartridges are sealed poly bags inside a rectangular cardboard box, 6 per case. All bottles are black plastic, 12 per case (2 oz & 4 oz bottles), or 6 per case (8 oz bottles). The 500 ml cartridges, and the 4 oz and 8 oz bottles are packaged under the GOJO brand label; and the 2 oz bottles are packaged under either the GOJO brand or Pro-Link brand labels. The product catalog numbers are as follows: #8242-06 (500 ml cartridges); #8142-12 (2 oz); #8147-12 (4 oz); #8145-06 (8 oz)
CODE Lot Numbers: 165461, 166095, 166581, 166826, 167503, 168453, and 168912.
RECALLING FIRM/MANUFACTURER GOJO Industries, Inc., Cuyahoga Falls, OH, by fax on March 26, 2002. Firm initiated recall is ongoing.
REASON Superpotency of the active ingredient (Benzalkonium Chloride).
VOLUME OF PRODUCT IN COMMERCE 9,703 cases.
DISTRIBUTION Nationwide.

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April 17, 2002 PROVON Medicated Lotion Soap (GoJo)-2002
PRODUCT PROVON Medicated Lotion Soap with Triclosan, OTC, packaged in 12 fl. oz. white plastic bottles. Active ingredient: Triclosan 0.3%, Product Number 4153-12. The bottles are packaged under the GOJO brand label. Recall # D–238-2. A case contains 12-12 fl oz bottles with a pump closure in cardboard box.
CODE Lots #169738 and #168862.
RECALLING FIRM/MANUFACTURER GOJO Industries, Inc., Cuyahoga Falls, OH, by fax on March 29, 2002. Firm initiated recall is ongoing.
REASON Misbranding: Back bottle label declares incorrect active ingredient.
VOLUME OF PRODUCT IN COMMERCE 37 cases.
DISTRIBUTION WI, IL, WA, MO, NE, LA, MA, and CA.

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May 29, 2002 Royal Jelly Milk Balm Moisture Lotion-2002
PRODUCT Royal Jelly Milk Balm Moisture Lotion, 1 oz. and 1.7 oz. For Dry to Normal Skin. Recall # F-447-2.
CODE Lots: UU1295B, UU1295A, UU1285A, UU1198B, UU1198A.
RECALLING FIRM/MANUFACTURER Recalling Firm: Jafra Cosmetics International, Westlake Village, CA, by letters on March 1, 2002. Manufacturer: Universal Packaging Systems, Inc. Chino, CA. Firm initiated recall is complete.
REASON The product was contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE 33,389.
DISTRIBUTION Nationwide.

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August 28, 2002 GOJO Skin Lotion Medicated-2002
PRODUCT GOJO Skin Lotion Medicated (Allantoin 0.7%), 5 fl oz tubes NET 148 mL. Recall # D-388-2. The catalog numbers and packaging configuration are as follows: #8140-24 (case of 24); #8140-24-B5P00 (case of 24); #8140-06-BH200 (case of 6); #8140-12-BYR00 (case of 12)
CODE LOT NUMBERS: 134239, 138256, 147523, 151914, 152499, 153752, 160436, 169565, 170833.
RECALLING FIRM/MANUFACTURER GOJO Industries, Inc., Cuyahoga Falls, OH, by fax on July 25, 2002. Firm initiated recall is ongoing.
REASON Subpotent; active ingredient Allantoin (stability).
VOLUME OF PRODUCT IN COMMERCE 12,719 cases.
DISTRIBUTION Nationwide.

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September 18, 2002 Aura Cacia Rich Moisturizing Shampoo-2002
PRODUCT Aura Cacia Rich Moisturizing Shampoo packaged in 12 and 32-fl. oz. bottles. Recall # F-756-2.
CODE 12-oz. bottles - Lots 2170 and 2171
32-oz. bottles - Lots 2171 and 2172.
RECALLING FIRM/MANUFACTURER Recalling Firm: Frontier Natural Brands, Norway, IA, by telephone on July 12, 2002. Firm initiated recall is ongoing.
REASON The product is contaminated with Enterobacter gergoviae.
VOLUME OF PRODUCT IN COMMERCE 5,752 bottles.
DISTRIBUTION Nationwide and Canada.

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September 18, 2002 Softsoap Antibacterial Liquid Hand Soap (with hand pump)-2002
PRODUCT Softsoap Antibacterial Liquid Hand Soap (with hand pump) Rainforest Series (triclosan), 7.5 FL OZ (221 mL) bottles. Recall # D-402-2.
CODE Rainforest product:
SKU Number 127800
Code dates 2134,2135,2136
Rainforest product mixed product displays:
SKU Number: 102781
Code Dates: 2158, 2161.
RECALLING FIRM/MANUFACTURER Colgate-Palmolive Co., Piscataway, NJ, by letters starting on July 2, 2002. Firm initiated recall is ongoing.
REASON Cross contamination with another soap product (contains undeclared ingredients: aloe vera, fragrance, glycerin, hydrolyzed silk).
VOLUME OF PRODUCT IN COMMERCE 19,293 cases.
DISTRIBUTION Nationwide.

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October 2, 2002 Listerine Essential Care Gel Toothpaste and Listerine Essential Care Tartar Control Gel Toothpaste-2002
PRODUCT a) Listerine Essential Care Gel Toothpaste, 0.9 oz tube (Eucalyptol 0.738%, Menthol 0.340%, Methyl salicylate 0.480%, Thymol 0.511%, Sodium monofluorophosphate 0.76% (0.13% Fluoride Ion). Recall # D-422-2;
b) Listerine Essential Care Tartar Control Gel Toothpaste, 0.9 oz tube, (Eucalyptol 0.738%, Menthol 0.340%, Methyl salicylate 0.480%, Thymol 0.511%, Sodium monofluorophosphate 0.76% (0.13% Fluoride Ion). Recall # D-423-2.
CODE All Lots packaged as follows:
Professional Samples -- Not for Retail Sale
Trial Size Tartar Control Gel Case UPC 1 03 12547 43450 5
Case containing 72/0.9 ounce tubes
Trial Size Gel
Case UPC 1 03 12547 43470 3
Case containing 72/0.9 ounce tubes.
Promotional Items as an on-pack with Listerine 1.0 L and 1.5 L (Gold, CoolMint, Fresh Burst, Tartar Control, Mixed Displays) Bottles.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pfizer, Consumer Healthcare Group, Morris Plains, NJ, by letters on May 22, 2002.
Manufacturer: Accupac, Inc., Mainland, PA. Firm initiated recall is ongoing.
REASON Subpotent; active ingredient Methyl salicylate (stability).
VOLUME OF PRODUCT IN COMMERCE 12,649,365 tubes.
DISTRIBUTION Nationwide and Puerto Rico.

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NOVEMBER 6, 2002 Hartz Advanced Care Brand Flea Control Capsules-2002
PRODUCT Hartz Advanced Care Brand Flea Control Capsules (s)-Methoprene with 8 capsules per package and 154 milligram per capsule for dogs and puppies 9 weeks of age or older weighing 11 to 15 lbs. Recall # V-005-3.
CODE Product Code: 32700-96718 Lot No.: 616601, Exp. Date June 14, 2004.
RECALLING FIRM/MANUFACTURER Recalling Firm: The Hartz Mountain Corp., Secaucus, NJ, by telephone on July 15, 2002. Manufacturer: The Hartz Mountain Corp., Bloomfield, NJ. Firm initiated recall is ongoing.
REASON Labeling and insert contained wrong body weight information.
VOLUME OF PRODUCT IN COMMERCE 18105 units.
DISTRIBUTION Nationwide.

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November 13, 2002 Paradise Gold SUNSCREEN BROAD SPECTRUM PROTECTANT-2002
PRODUCT Paradise Gold SUNSCREEN BROAD SPECTRUM PROTECTANT
(Octinoxate, Octisalate, Oxybenzone, Avobenzone), SPF 15, 8 FL OZ (237 mL), Exclusively at Walgreens, Deerfield, IL. Recall # D-046-3.
CODE 2096B
RECALLING FIRM/MANUFACTURER Recalling Firm: Tanning Research Laboratories, Inc., Ormond Beach, FL, by letter on July 11, 2002.
Manufacturer: Tanning Research Laboratories, Ormond Beach, FL. Firm initiated recall is complete.
REASON Mislabeling; back label on bottle incorrectly declared as SPF 30 rather than the correct SPF 15.
VOLUME OF PRODUCT IN COMMERCE 5400
DISTRIBUTION IL, WI, FL, TX, CA, PA, AZ and IN.

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November 20, 2002 Pyrethrin Lice Treatment, Kinray Preferred Plus brand, A Creme Rinse Application-2002
PRODUCT Pyrethrin Lice Treatment (Piperonyl Butoxide 4% and Pyrethrum Extract (equivalent to 0.33% Pyrethrins), Kinray Preferred Plus brand, A Creme Rinse Application, 2 fl. oz. (59 mL) bottles, single and twin packs. Recall # D-054-3.
CODE 2F15A, exp. June 2004 (single unit)
2G02A, exp. July 2004 (twin pack)
2G25D, exp. July 2004 (twin pack).
RECALLING FIRM/MANUFACTURER Qualis, Inc., Des Moines, IA, by telephone on October 28, 2002.
Firm initiated recall is ongoing.
REASON Mislabeling; one active ingredient is incorrectly declared on the bottle label as Permethrin rather than correctly as Pyrethrin.
VOLUME OF PRODUCT IN COMMERCE 504 single units and 384 twin packs; 118 single packs and 245 twin packages have been quarantined at the own-label distributor awaiting return to Qualis.
DISTRIBUTION NY


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