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Health product recall

Red Bum Balm (2015-01-26)

Starting date:
January 26, 2015
Posting date:
February 2, 2015
Type of communication:
Drug Recall
Subcategory:
Natural health products, Affects children, pregnant or breast feeding women
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-43575

Recalled Products

Red Bum Balm

Reason

Product recalled due to no market authorization, unauthorized claims, lack of safety evidence for the subpopulation (Infants) and the possibility for irritation / sensitization.

Depth of distribution

Retailers

Affected products

Red Bum Balm

DIN, NPN, DIN-HIM

No Market Authorization

Dosage form

Cream

Strength

Shea butter (Butyrospermum Parkii)

Cocoa butter (Theobroma Cacoa)

Calendula oil (Calendula Officinalis)

St.John’s Wort (Hypericum Perforatum)

Carrot oil (Daucus Carota Sativa)

Beeswax (Cera Flava)

Lavender oil (Lavandula Vera)

Orange oil (Citrus Aurantium Amara)

Tea tree oil (Melaleuca Alternifolia)

Vitamin E (Tocopherol)

Vitamin B5 (Panthenol)

Lot or serial number

ATX09

ATX04

ATX01

Companies
Recalling Firm

Baby and Eve

1 Yonge Street, Suite 1801

Toronto

M5E 1W7

Ontario

CANADA

Marketing Authorization Holder

Not Applicable