THE FOOD AND DRUG ADMINISTRATION IS ADVISING CONSUMERS TO STOP USING CERTAIN COSMETIC “FACE PAINT” ITEMS LABELED AS DISTRIBUTED BY ORIENTAL TRADING CO., OMAHA, NEB., DUE TO ADVERSE EVENT REPORTS OF SKIN REACTIONS IN CHILDREN. THESE ITEMS WERE DISTRIBUTED NATIONWIDE.
THE FDA HAS LEARNED OF A CLUSTER OF ADVERSE EVENTS IN CHILDREN EXPOSED TO VARIOUS COLORS OF THE FACE PAINT. ALL EXPOSURES OCCURRED ON THE SAME DAY AT AN ORGANIZED EVENT AND INCLUDED RASHES, ITCHINESS, BURNING SENSATION, AND SWELLING WHERE THE FACE PAINTS WERE APPLIED. SIGNIFICANT MICROBIAL CONTAMINATION WAS INDICATED IN MOST OF THE PRODUCTS IN TESTING BY AN FDA LABORATORY.
THE FOLLOWING FACE PAINTS MANUFACTURED BY SHANGHAI COLOR ART STATIONERY COMPANY LIMITED, SHANGHAI, CHINA, ARE BEING VOLUNTARILY RECALLED BY FUN EXPRESS INC., A WHOLLY-OWNED SUBSIDIARY OF ORIENTAL TRADING CO.:
|
ITEM NUMBER |
PRODUCT DESCRIPTION |
UNIVERSAL PRODUCT CODE (UPC) |
|---|---|---|
|
85/2077 |
BLUE FACE PAINT |
8 8760048110 7 |
|
85/2078 |
PURPLE FACE PAINT |
8 8760048112 1 |
|
85/2079 |
RED FACE PAINT |
8 8760048114 5 |
|
85/2080 |
ORANGE FACE PAINT |
8 8760048116 9 |
|
85/2081 |
BLACK FACE PAINT |
8 8760048118 3 |
|
85/2082 |
GREEN FACE PAINT |
8 8760048120 6 |
FUN EXPRESS INC. IS RECALLING THE FACE PAINTS FROM THE MARKET AND FDA ADVISES CONSUMERS TO STOP USE OF THESE PRODUCTS AND DISCARD THEM OR RETURN THEM TO THE RETAILER.
THE FDA ENCOURAGES CONSUMERS AND HEALTH CARE PROVIDERS TO REPORT ANY ADVERSE EVENTS FROM FACE PAINTS TO THE FDA AS WELL AS TO STATE AND LOCAL HEALTH AUTHORITIES.
ADVERSE EVENTS AND PRODUCT QUALITY PROBLEMS CAN BE REPORTED TO FDA’S MEDWATCH ADVERSE EVENT REPORTING PROGRAM:
ONLINE AT WWW.FDA.GOV/MEDWATCH/REPORT.HTM BY CALLING 1-800-FDA-1088 BY RETURNING THE POSTAGE-PAID FDA FORM 3500 (WHICH MAY BE DOWNLOADED FROM WWW.FDA.GOV/MEDWATCH/GETFORMS.HTM) BY MAIL TO MEDWATCH, 5600 FISHERS LANE, ROCKVILLE, MD 20852-9787 BY FAX 1-800-FDA-0178
PHOTO: PRODUCT LABEL: HTTP://WWW.CFSAN.FDA.GOV/~DMS/COSADV.HTML
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