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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