Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services
FDA, U.S. Food and Drug Administration
U.S. Food & Drug Administration
 
  • A to Z Index
  • Follow FDA
  • FDA Voice Blog
Search
 
Most Popular Searches
 
  • Home
  • Food
  • Drugs
  • Medical Devices
  • Vaccines, Blood & Biologics
  • Animal & Veterinary
  • Cosmetics
  • Radiation-Emitting Products
  • Tobacco Products
 

Import Alert 53-17

  • Print
  • Share
  • E-mail
  • FDA Home
  • Import Program
  • Import Alerts
  • Imports Alerts by Number
  • Import Alert
-

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 53-17
Published Date: 05/15/2013
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"

Reason for Alert:
Laboratory analyses have found Citrobacter freundii and Pseudomonas stutzeri in eyeshadow and Xanthomonas maltophilia and a high aerobic plate count in the eyeshadow component of a make-up kit. In addition, a high count of Staphylococcus saprophyticus was found in the lipstick components of a cosmetic tote bag.

Guidance:
Districts may detain, without physical sampling and analysis all cosmetics, such as lipstick and/or eyeshadow, including make-up kits/cosmetic tote bags containing these components, from firms identified in the attachment for this alert.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:
Cosmetics

Charge:
"The article [eyeshadow, make-up kit, cosmetic tote bag] is subject to refusal of admission pursuant Section 801(a)(3) in that the eyeshadow/eyeshadow component of the make-up kit/cosmetic tote bag appears to contain a poisonous or deleterious substance which may render it injurious to health. [Adulteration, Section 601(a)]."

OASIS charge code - POISONOUS

AND/OR

"The article [lipstick, make-up kit, cosmetic tote bag] is subject to refusal of admission pursuant Section 801(a)(3) in that the eyeshadow component of the make-up kit and the lipstick component of the cosmetic tote bag appear to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth. [Adulteration, Section 601(c)]."

OASIS charge code - COSMETIC


List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)



BELGIUM

Laboratoires Ndv
Date Published : 04/13/2012

B 1930 Zaventen , Brixtonlaan, BELGIUM
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 04/13/2012

Desc:Nelly De Vust Slimming Oil
Notes:Staphyloccus xylosus


CANADA

Apollo Nutraceuticals Inc
Date Published : 03/14/2011

20 Graniteridge Rd , Concord, ON CANADA
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 03/14/2011

Desc:Daily Skin Facial Scrub
Notes:601(a) Staphylococcus Hominis

Apollo Nutraceuticals Inc
Date Published : 03/14/2011

20 Graniteridge Rd , Concord, ON CANADA
53 L - - 09 Skin Fresheners (Skin Care Preparations)
Date Published: 03/14/2011

Desc:Daily Skin Facial Scrub
Notes:601(a) Staphylococcus Hominis

Bio Botanical Labs Inc.
Date Published : 09/18/2009

2555 Boul. Des Sources , Pointe-Claire, Quebec CANADA
53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products)
Date Published: 06/15/2010

Desc:Li'l Goat's Milk Moisturing Lotion
Notes:601(a) gram negative rods and enterobacter gergoviae
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 09/18/2009

Desc:Clearly Natural Brand; 6/18/03
Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;

Bio Botanical Labs Inc.
Date Published : 09/18/2009

2555 Boul. Des Sources , Pointe-Claire, Quebec CANADA
53 A D - 01 Baby Shampoo (Baby Products)
Date Published: 05/20/2011

Desc:Lil Goat's Milk Shampoo and Body Wash
Notes:601 (a) Enterobacter gergoviae
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 09/18/2009

Desc:Clearly Natural Brand; 6/18/03
Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;

Demco Manufacturing Inc
Date Published : 09/18/2009

5485 Ramsay , Saint-Hubert, QC CANADA
53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc:Crayon Face Paint Markers;8/9/07
Notes:601(a);Yeast/mold;viable gram positive rods
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc:Crayon Face Paint Markers;8/9/07
Notes:601(a); yeast/mold; viable gram postive rods
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Crayon Face Paint Markers;8/9/07
Notes:601(a); Yeast/mold; viable gram positive rods

Estee Lauder
Date Published : 07/20/2011

217 Idema Rd , Markham, ON CANADA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 07/20/2011

Desc:MAC Double Feature 4 Tealdrop (WN)/Original Ochre (WN) Eyeshadow
Notes:601 (a) Sphingomonas; paucimobilis;shewanella putrefaciens

Golden Moor
Date Published : 02/16/2011

38 Indsutiral , Casselman, ON CANADA
53 B D - 99 Other Bath Preparations, N.E.C.
Date Published: 06/02/2011

Desc:Bain de Boue (Mud Bath)
Notes:601(a) Enteroccus faecalis Pseudmonas putida Stenotrophomonas maltophilia Enterobacter amnigenus Acinetobacter radioresistens
53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 02/16/2011

Desc:Natural Face Mask
Notes:601(a) Pseudomonas putida and Pseudomonas jluorescens

Les Productions Pupazzo
Date Published : 01/25/2013

788 Avenue Greene , Montreal, QUEBEC CANADA
53 A - - 02 Lotions, Oils, Powders and Creams (Baby Products)
Date Published: 01/25/2013

Desc:Pupazzo Soothing face & Body Milk (Delicate Fragrance)
Notes:601(a) P. aeruginosa

Strauss Enterprises Limited dba Strauss Herb Company
Date Published : 03/01/2011

755 Fortune Drive , Kamloops, BC CANADA
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 03/01/2011

Desc:Herb Company Shampoo
Notes:601(a) Enterobacter gergoviae; Klebsiella oxytoca; and Raoultella omithinolytica
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 03/01/2011

Desc:Herb Company Moisturizing Body Wash
Notes:601(a) Enterobacter gergoviae; Klebsiella oxytoca; and Raoultella omithinolytica


CHINA

Beauty Vision Ltd.
Date Published : 06/23/2011

Blk.c,bao Tong Ind.dist.tong Mei Village , Gong Ming Town,bao An County, , Shenzhen, CN-44 CHINA
53 C H - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 06/23/2011

Desc:Eye Shadow and Lip-Gloss (Contained in Bratz Makeup Design Sketch Book)
Notes:601(a) Staphylococcus intermedius; Staphylococcu warneri; Gram Positive Coccus
53 G K - 06 Makeup Bases (Makeup Preparations, not for Eyes)
Date Published: 06/23/2011

Desc:Eye Shadow and Lip-Gloss (Contained in Bratz Makeup Design Sketch Book)
Notes:601(a) Staphylococcus intermedius; Staphylococcu warneri; Gram Positive Coccus

Elle Jewelry Corp
Date Published : 09/18/2009

37-3 Nong Gong Road Yiwu , Zhejiang, CHINA
53 C - - 02 Eyeliner (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Lip.eye line pencil; 3/31/03
Notes:601(c)
Problems: CHRYSEOMONAS : LUTEOLA; PSEUDOMONAS : NOT SPECIATED;
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:lip/eye liner pencil; 3/31/03
Problems: CHRYSEOMONAS : LUTEOLA; PSEUDOMONAS : NOT SPECIATED;

Great Eagle Manufacture
Date Published : 11/26/2012

Blk No 6 Tung Fu Industrialda Peng Long , Shenzen, CHINA
53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes)
Date Published: 11/26/2012

Desc:Disney Fairies Pixie Hollow Simmering Kit
Notes:601(a) B. Cepacia
53 G - - 10 Children Novelty Face Makeup Kits
Date Published: 11/26/2012

Desc:Disney Fairies Pixie Hollow Simmering Kit
Notes:601(a) B. Cepacia

Johns Cosmetic
Date Published : 09/18/2009

Li Lang Da Dao , Shenzhen, CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Multi-use Eye Shadow; 3/15/05
Notes:601(a); gram positive and negative bacteria
Problems: CITROBACTER; STAPHYLOCOCCUS : AUREUS;
53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Multi-use Eye Shadow; 3/15/05
Notes:601(a); gram pos and neg bacteria
Problems: CITROBACTER; STAPHYLOCOCCUS : AUREUS;

Ningbo Hiking Imp & Exp Co., Ltd.
Date Published : 09/18/2009

139 Yaohank Street, Room 2209 , Ningbo, CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Le Le Make up set; 1/25/07
Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;
53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Le Le Make-up Set; 1/25/07
Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;

Shanghai Color Art Stationery Company Limited
Date Published : 09/30/2009

85 Xingchuansha Road , Loujing, Boashan , Qu Shanghai, CHINA
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 09/30/2009

Desc:Face and Body Paints
Notes:601 (a) Yeast/Mold Gram Positive Rods High Aerobic Plates Counts 7/15/09

Sheencolor Bitech Co Ltd
Date Published : 02/16/2012

Liawan Industrial Zone Pingsha Jinwan D. , Zhuhai, Guangdong CHINA
53 G - - 05 Lipstick (Makeup Preparations, not for Eyes)
Date Published: 02/16/2012

Desc:Alexia Lip Gloss
Notes:601(a) Pseudomonas aeruginosa Sphingomonas paucimobilis

Shenzhen Yada Cosmetics Co Ltd
Date Published : 09/18/2009

4/F 02 Bld Fuzhao Center Buxin Rd , Shenzhen, CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Eye Shadow; 7/14/03
Notes:601(c)
Problems: PSEUDOMONAS; CHRYSEOMONAS;

Xiamen Royal Bath Accessories Co
Date Published : 09/18/2009

No#5 Building,Pan Tu Ind.Estate , Xiamen City,China, CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:4/14/08
Notes:601(a); high aerobic plate count identified as Stenotrophomonas maltophilia (Pseudomonas)
Problems: PSEUDOMONAS : MALTOPHILIA;

Xiamen Royalbath Accessories Co., ltd
Date Published : 09/18/2009

#2135, Yan-shen Duan, Huli Da Dao, , Zhongzhai County, Heshan Town, Huli , Xiamen, CN-35 CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:4/14/08
Notes:601(a) high aerobic plate count identified as Stenotrophomonas maltophilia (Pseudomonas)
Problems: PSEUDOMONAS : MALTOPHILIA;

Yiwu Siya Cosmetics
Date Published : 09/18/2009

109-1 Cosmetic Market , Yiwu, Zhejiang, CHINA
53 C - - 01 Eyebrow Pencil (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Eye Pencil; 3/1/05
Notes:601(a); non spore forming gram pos rods; coagulase neg and gram pos cocci; gram neg rods
Problems: ACINETOBACTER; PSEUDOMONAS;
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:3/1/05
Notes:601(a); non spore forming gram pos rods; coagulase neg and gram pos cocci; gram neg rods
Problems: PSEUDOMONAS; ACINETOBACTER;
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:eye shadow; eye pencil; cream eye shadow; 3/1/05
Notes:601(a); non spore forming gram pos rods; coagulase neg and gram pos cocci; gram negative rods
Problems: PSEUDOMONAS; ACINETOBACTER;

Zhongshan Metro Cosmetics Ind Co Lt
Date Published : 09/18/2009

No 1 Shunming St , Zhongshan City, CHINA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Cosmetic Sets; 3/31/03
Notes:601(c); multiple micro contamination; unidentified gram neg non-fermenters; Actinobacillus ureae; Shingomonas paucimobilis
Problems: ACINETOBACTER : JUNII; ACINETOBACTER : LWOFFI; ACTINOBACILLUS : NOT LISTED, IDENTIFY IN REMARKS; AGROBACTERIUM : RADIOBACTER; STAPHYLOCOCCUS : AURICULARIS; OCHROBACTRUM : ANTHROPI; PASTEURELLA : HAEMOLYTICA; PHOTOBACTERIUM; CHRYSEOMONAS : LUTEOLA;

Zhuhai Maxis Cosmetics Prod.Co. Ltd
Date Published : 09/18/2009

6e Nanxi Industry District #A2 , Qinshan, , Zhuhai City, Guangdong CHINA
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Eye Shadow Kit; 7/14/03
Notes:601(c); multiple micro contamination; Sphingomonas paucimobilis
Problems: ACINETOBACTER : JUNII; ACINETOBACTER : LWOFFI; PASTEURELLA : TREHALOSI; PASTEURELLA : HAEMOLYTICA; PASTEURELLA : MULTOCIDA; CHRYSEOMONAS : LUTEOLA;


FRANCE

Vitry Sa
Date Published : 01/06/2011

Pa De La Foret , Bignon, FRANCE
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 01/06/2011

Desc:Longcils Boncza Cake Mascara Black
Notes:601(a) Gram Positive rods non-sporeforming


GERMANY

United Brands Marketing Gmbh
Date Published : 09/18/2009

Korngasse 12a , Niederkassel, GERMANY
53 C - - 02 Eyeliner (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Eyeliner; 11/20/07
Notes:601(a)
Problems: ENTEROCOCCUS;


INDIA

CUCKU ENTERPRISES PVT. LTD.
Date Published : 05/15/2013

G-12, JAWAHAR NAGAR, , Delhi, Delhi INDIA
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 05/15/2013

Desc:Herbal Neem Powder
Notes:601(c)Patoea spp.; B. licheniformis; B. curculans; and B. vallismortis


INDONESIA

PT Surya Garutindah (Perseroan Terbatas)
Date Published : 02/02/2010

JL Pataruman , No. 47 Garut 44151 , Jawa Barat, INDONESIA
53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 08/28/2010

Desc:All Eyelash Kits (With and without Glue)
Notes:601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10
53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 08/28/2010

Desc:All Eyelash Kits (With and without Glue)
Notes:601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/28/2010

Desc:All Eyelash Kits (With and without Glue)
Notes:601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10


ITALY

Gamma Croma S.P.A.
Date Published : 09/18/2009

Strada Statale Paullese 415 , Km 29 , Vaiano Cremasco, ITALY
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Notes:Eye shadow
Problems: STAPHYLOCOCCUS : HOMINIS; BACILLUS : CEREUS;


KOREA, REPUBLIC OF (SOUTH)

H & K Korea Corp.
Date Published : 01/18/2013

No. 307 3f Woori Bldg. 47-17 Sin , Seoul, KOREA, REPUBLIC OF (SOUTH)
53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 01/18/2013

Desc:Hydrogel Eye Patch
Notes:601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.
53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 01/18/2013

Desc:Hydrogel Eye Patch
Notes:601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.
53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 01/18/2013

Desc:Hydrogel Eye Patch
Notes:601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 01/18/2013

Desc:Hydrogel Eye Patch
Notes:601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 01/18/2013

Desc:Hydrogel Eye Patch
Notes:601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 01/18/2013

Desc:Hydrogel Eye Patch
Notes:601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 01/18/2013

Desc:Hydrogel Eye Patch
Notes:601(a);Organisms recovered include Bacillus firmus, Staphylococcus warneri, Burkholderia cepacia and Brevibacillus choshinensis.

Pacific Corporation
Date Published : 09/18/2009

CPO Box 195 , Seoul, KOREA, REPUBLIC OF (SOUTH)
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:eye shadow; 5/16/95
Notes:601(a)
Problems: PSEUDOMONAS : STUTZERI;

Seowoo Int Corp
Date Published : 02/02/2010

229 Chungjeon Rezion 465 , 3-ga Chungjeong-ro, Seodaemun-gu , Seoul, KOREA, REPUBLIC OF (SOUTH)
53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 08/28/2010

Desc:All Eyelash Kits (With and without Glue)
Notes:601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10
53 C - - 09 Children Novelty Eye Makeup Kits
Date Published: 08/28/2010

Desc:All Eyelash Kits (With and without Glue)
Notes:601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/28/2010

Desc:All Eyelash Kits (With and without Glue)
Notes:601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10


MEXICO

Baja Fur S A De C V
Date Published : 02/02/2010

Calle Romano 1352 , Tijuana Bc Mexico, MEXICO
53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 08/28/2010

Desc:ALl Eyelash Kits (With and without Glue)
Notes:601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10
53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 08/28/2010

Desc:All Eyelash Kits (With and without Glue)
Notes:601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/28/2010

Desc:All Eyelash Kits (With and without Glue)
Notes:601(a) Pseudomonas spp. and Staph aureus; Update product listing 8/28/10

Christian Cosmeticos
Date Published : 05/21/2012

Bahia De Los Angeles 3432 , Tijuana Baja Cfa, MEXICO
53 C H - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 05/23/2012

Desc:Christian Eyebrow makeup black
Notes:601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus
53 C H - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 05/23/2012

Desc:Christian Eyebrow makeup Bronzed
Notes:601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus
53 C H - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 05/23/2012

Desc:Christian Eyebrow makeup Charcoal
Notes:601 (a) adulteration;Aerococcus viridans, Alicyclobacillus acidoterrestris/ acidocaldarius/Brevibacillus choshinensis, B.cereus/thuringiensis/mycoides, B. pumilus, B. lentus, B. firmus, B. megaterium, B. vallismortis, B. subtilis/amyloliquefaciens/atrophaeus, enterobacter cloacae complex, Kocuria varians, Lysinibacillus sphaericus/Lysinicacillus fusiformis/Brevibacillus choshinensis, Moraxella lacunata/nonliquefaciens/osloensis, Paenibacillus alvei, Paenibacillus polymyxa, Pseudomonas stutzeri, Serratia liquefacien, Sphingomonas paucimobilis, S. aureus, S. epidermidis, S. homnis ssp. Hominis, S. saprophyticus, and Virgibacillus pantothenticus
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 05/21/2012

Desc:Eyebrow Make Up Kits
Notes:601(a); Organisms recovered include Gram negative Pseudomonas oryzihabitans; Gram negative Pantoea spp; Gram positive rods; Gram negative Sphingomonas paucimobilis; Gram positive; Micrococcus spp; Oxidase positive; non-lactose fermenting and Gram positive spore forming bacillus; Pseudomonas Stutzeri; Sphingomonas paucimobilis; S. epidermidis; S. hominis; S. warneri; Serratia fonticola; Yeast and Mold.

Comercial Urania Sa De Cv
Date Published : 05/29/2012

Saltillo No 119 Col Exhipodromocondesa , Mexico, MEXICO
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 05/29/2012

Desc:Moisturizing Cream
Notes:601(a) B. gladioli
53 G - - 03 Foundations (Makeup Preparations, not for Eyes)
Date Published: 05/29/2012

Desc:Moisturizing Cream
Notes:601(a) B. gladioli
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 05/29/2012

Desc:Moisturizing Cream
Notes:601(a) B. gladioli
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/29/2012

Desc:Moisturizing Cream
Notes:601(a) B. gladioli

Commercializadora Intergral Belleza Sa Cv
Date Published : 04/20/2012

Calle Ticoman No14 Tepeyac Insurgentes , Mexico City, MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 04/20/2012

Desc:Mascara with Avocado oil
Notes:601(a) Enterococcus faecium

Cosmetobellezas Natural S.A De C.V.
Date Published : 09/18/2009

Martin Luis Guzman 215 Col. Iztaccihuatl , Mexico D.F., MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Mascara w/mamey seed oil;7/15/03
Notes:601(a); gram negative rods

Dermatisse Cosmeticos S.A. De C.V.
Date Published : 03/14/2011

Av. San Jeronimo 506-A Col. San Jeronimo , Monterrey, MEXICO
53 C - - 02 Eyeliner (Eye Makeup Preparations)
Date Published: 03/14/2011

Desc:Eyeshadow Compact Dermatisse Brand
Notes:601(a) Pseudomonas stutzeri; and shewanella Putrefaciens
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 03/14/2011

Desc:Eyeshadow Compact Dermatisse Brand
Notes:601(a) Pseudomonas stutzeri; and shewanella Putrefaciens
53 G - - 05 Lipstick (Makeup Preparations, not for Eyes)
Date Published: 03/14/2011

Desc:Eyeshadow Compact Dermatisse Brand
Notes:601(a) Pseudomonas stutzeri; and shewanella Putrefaciens
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 03/14/2011

Desc:Eyeshadow Compact Dermatisse Brand
Notes:601(a) Pseudomonas stutzeri; and shewanella Putrefaciens

Framesi Laboratorios, S.A. de C.V.
Date Published : 09/18/2009

Miguel Cruz Afdo., No. 10-B , Col. Flores Magon , Mexico, D.F. MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Mascara with mamey seed oil; 9/4/03
Notes:601(c); multiple micro contaminants & non-fermentative gram negative rods and gram positive rods with spores
Problems: ENTEROBACTER : CLOACAE;
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Mascara w/avocado oil; 5/5/04
Notes:601(a)
Problems: ENTEROBACTER : CLOACAE; PSEUDOMONAS : AERUGINOSA; LECLERCIA : ADECARBOXYLATA; KLEBSIELLA : PNEUMONIAE;

Laboratorios Naturamex
Date Published : 09/18/2009

Calle Morelos Sur 899 , Col. Ventura Puente , Morelia, Michoacan MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Avocado seed oil & mamey seed oil; 3/25/04
Notes:multiple micro contaminants including yeast/mold; gram positive rods; gram negative rods
Problems: STAPHYLOCOCCUS; CHRYSEOMONAS : LUTEOLA;

MEGAMIX
Date Published : 09/18/2009

Calle Antonio Alzate #71 Int. "A" Centro , Morelia, MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Notes:5/10/05
53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 09/18/2009

Notes:Mascara;5/10/05

PROSA productos naturales S.A. de C.V.
Date Published : 09/18/2009

Cda. Sur 57 No. 174 , Colonia Transito , Mexico D.F., MX-MEX MEXICO
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Mascara w/mamey seed oil;9/23/03
Notes:601(a); gram positive and gram negative bacilli

Probelco S.A. de D.V.
Date Published : 09/18/2009

Biznaga No. 43, Col. Las Palmas , Mexico, D.F., MEXICO
53 C - - 02 Eyeliner (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:7/25/08
Notes:601(a)
Problems: PSEUDOMONAS : PUTIDA;


MOROCCO

Lesieur Cristal
Date Published : 07/25/2011

No. 1, Rue Caporal Corbiroches Noires , Casablanca, MOROCCO
53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)
Date Published: 07/25/2011

Desc:Soap 100% Clay
Notes:601(a) Pseudomonas Stutzeri Cronobacter spp. Acinetobacter radiocresistens


NETHERLANDS ANTILLES

ATM, Inc. (Curacao)
Date Published : 09/18/2009

Curazao Free Zone , Maduro Plaza , Willemstad, NETHERLANDS ANTILLES
53 E - - 06 Shampoos (Hair Preparations, Non-coloring)
Date Published: 09/18/2009

Desc:Pantene hydrating curls (counterfeit); 11/5/04
Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;


PAKISTAN

Taimoor Enterprises
Date Published : 09/18/2009

Flat 28-29 2nd Floor P.M.C. , Khyber Bazar Peshawar, PAKISTAN
53 C - - 02 Eyeliner (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Surma; eye liner; black powder; 1/23/07
Notes:601(a); 601(c); a variety of microbes present; yeast and mold; Sphinomonas paucimoblis; M. haemolytica
Problems: STAPHYLOCOCCUS : AUREUS; ESCHERICHIA : COLI (TYPICAL);


PERU

Labratorios Producto Jumam E.I.R.L.
Date Published : 09/18/2009

Jr. Pastaza 740 , Brena, PERU
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/18/2009

Desc:Baba de Caracol Skin Cream; 8/3/07
Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/18/2009

Desc:mfr; Baba de Caracol Skin Cream; 8/3/07
Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;

PRODUCTOS JUMAM EIRL
Date Published : 09/18/2009

PASTAZA STREET 740 BRENA , LIMA, PE-LIM PERU
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/18/2009

Desc:mfr; Baba de Caracol Skin Cream; 8/3/07
Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/18/2009

Desc:mfr; Baba de Caracol Skin Cream; 8/3/07
Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;

Productod Jumam E.I.R.L
Date Published : 09/18/2009

Av Bolivia 1014 Brena , Lima, PERU
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/18/2009

Desc:shipper; Baba de Caracol Skin Cream; 8/3/07
Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/18/2009

Desc:Shipper; Baba de Caracol Skin Cream; 8/3/07
Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;


SINGAPORE

Lvmh Fragranc Cosmetics
Date Published : 04/11/2012

31 Jurong Port Rd , Jurong Logistics Hub, SINGAPORE
53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 04/11/2012

Desc:Natural Face Mask
Notes:601(a) Enterococcus casseliflavus; Microccus luteus and Staphylococcus lentus


TAIWAN

Chao Ling Chemical Ind. Co., Ltd.
Date Published : 09/18/2009

21, Pu Ting Road , p o box 442 , Hsinchu, TAIWAN
53 C - - 08 Eye Makeup Kits (Eye Makeup Preparations)
Date Published: 09/18/2009

Notes:601(a)
Problems: PSEUDOMONAS : AERUGINOSA;

Color Dreams
Date Published : 09/18/2009

No. 7, Lane 50, Nan Kung St , Yung Kang City, Tainan Hsien TAIWAN
53 G - - 01 Blushers (all Types) (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc:Face Color Cosmetic; 7/14/06
Notes:601(a)
Problems: STAPHYLOCOCCUS : AUREUS;

Lucky Seeds International
Date Published : 05/13/2010

2 Fl No. 1, Alley 3 Lane 13 , Kuh Luen Street , Taipei, TAIWAN
53 C - - -- Eye Makeup Prep
Date Published: 05/13/2010

Desc:Eye Makeup Kits
Notes:601(a) S. epidermidis

Maxigen Biotec, Inc.
Date Published : 09/18/2009

No 17 Wuchivan 8th Rd Wugu , Shiang Taipei, TAIWAN
53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)
Date Published: 09/18/2009

Notes:601(a)
Problems: ACINETOBACTER : CALCOACETICUS; PSEUDOMONAS : MALTOPHILIA;
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/18/2009

Desc:Proto-Coll Anti-age Face Mask; 7/8/05
Notes:601(a)
Problems: PSEUDOMONAS : MALTOPHILIA; ACINETOBACTER : CALCOACETICUS;
53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations)
Date Published: 09/18/2009

Notes:601(a)
Problems: PSEUDOMONAS : MALTOPHILIA; ACINETOBACTER : CALCOACETICUS;

Modish Collection International Co Ltd.
Date Published : 09/18/2009

No. 18 Lane 311 Cheng Chiang St , Tainan County, TAIWAN
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:Mascara; 3/10/05
Notes:601(a); spore forming gram pos rods; yeast
Problems: PSEUDOMONAS : NOT SPECIATED; STAPHYLOCOCCUS : AUREUS;
53 C - - 99 Other Eye Makeup Preparations, N.E.C.
Date Published: 09/18/2009

Desc:Mascara
Notes:3/10/05; spore forming gram positive rods and yeast
Problems: PSEUDOMONAS : NOT SPECIATED; STAPHYLOCOCCUS : AUREUS;

Prince Chemical Ind Co Ltd
Date Published : 09/18/2009

No 12 Hsin Jen Road , Tainan, TAIWAN
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc:3/31/95
Notes:601(a)
Problems: CITROBACTER : FREUNDII;
53 G - - 05 Lipstick (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc:3/31/95
Notes:601(c)
Problems: STAPHYLOCOCCUS : SAPROPHYTICUS;
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Cosmetic Tote bags containing lipstick and/or eyeshadow; 5/16/95
Notes:601(a); 601(c)
Problems: STAPHYLOCOCCUS : SAPROPHYTICUS; CITROBACTER : FREUNDII;


THAILAND

S&J International Enterprises Publi
Date Published : 04/05/2012

600/4 Moo 11, Sukaphiban 8 Road , Sriracha, THAILAND
53 C - - 03 Eye Shadow (Eye Makeup Preparations)
Date Published: 04/05/2012

Desc:Body Shop Eye Colour 32 Chocolate
Notes:601(a) Pseudomonas stutzeri, Acinetobacter Iwoffi, Micrococcus luteus and Moraxella nonliquifaciens

Siam Quality Industries Co Ltd
Date Published : 09/18/2009

49 Moo 1, Bangbuatong-Ladbualuang Road , Sainoi , Nonthaburi, THAILAND
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc:Crayon Face Paints; 5/16/06
Notes:601(a); gram pos spore forming rods; yeast; mold
Problems: STAPHYLOCOCCUS : AUREUS;
53 G - - 09 Face Makeup Kits (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc:Crayon Face Paint; 5/16/06
Notes:601(a); gram pos spore forming rods; yeast; mold
Problems: STAPHYLOCOCCUS : AUREUS;
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc:Crayon Face Paints; 5/16/06
Notes:601(a); gram pos spore forming rods; yeast; mold
Problems: STAPHYLOCOCCUS : AUREUS;
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Crayon Face Paints; 5/16/06
Notes:601(a); gram pos spore forming rods; yeast; mold
Problems: STAPHYLOCOCCUS : AUREUS;


UNITED KINGDOM

Lf Beauty
Date Published : 04/09/2010

Aintree House , Trowbridge Wisconsin Great Bri, UNITED KINGDOM
53 C - - 06 Mascara (Eye Makeup Preparations)
Date Published: 04/09/2010

Desc:The Body Shop Define and Lengthen Mascara
Notes:601(a); B. licheniformis, B. cereus

-
-

Links on this page:

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.


  • Accessibility
  • Contact FDA
  • Careers
  • FDA Basics
  • FOIA
  • No Fear Act
  • Site Map
  • Transparency
  • Website Policies
FDA
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA
  • USA.gov
  • E-mail
  • RSS
  • Twitter
  • Facebook
  • YouTube
  • Flickr
  • For Government
  • For Press
  • Combination Products
  • Advisory Committees
  • Science & Research
  • Regulatory Information
  • Safety
  • Emergency Preparedness
  • International Programs
  • News & Events
  • Training and Continuing Education
  • Inspections/Compliance
  • State & Local Officials
  • Consumers
  • Industry
  • Health Professionals
U.S. Department of Health & Human Services
 

Links on this page: