 |
Food and Drug Administration Actions:
Recalls and Field Corrections
2002-February 1, 2007
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 |
Back to top
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 |
Back to top
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 |
Back to top
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 |
Back to top
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 |
Back to top
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 |
Back to top
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 |
Back to top
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 |
Back to top
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. |
Back to top
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 |
Back to top
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. |
Back to top
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 |
Back to top
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 |
Back to top
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 |
Back to top
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 |
Back to top
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 |
Back to top
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 |
Back to
top
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. |
Back to top
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 |
Back to top
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. |
Back to top
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. |
Back to top
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. |
Back to top
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. |
Back to top
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 |
Back to top
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 |
Back to top
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. |
Back to top
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. |
Back to top
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. |
Back to top
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. |
Back to top
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. |
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