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The following 4 products were sold in a kit called the Baby Blanket Sun Smart Survival Kit: Baby Blanket Tend Scalps SPF 45 Baby Blanket Sunscreen Spray SPF 45 Baby Blanket Faces Sunblock SPF 45 Baby Blanket Sunblankie Towelette SPF 45 (December 23, 2009)

Starting date:
December 23, 2009
Posting date:
February 15, 2010
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-2010A46

Reason

Zellers does not have an EL to import human drugs. Even though the percentage of octocrylene varies in the 4 products, a single DIN is listed for the whole kit. In addition, octocrylene was not listed as an active ingredient in the registration of the DIN. Various technical labelling violations, (e.g.. no expiry date, improper format / lack of a lot number, no importer's information on label, lack of adequate directions for use in French), have also been identified.

Depth of distribution

The kits were distributed to Zellers' retail stores. The kits were not exported.

Affected products

The following 4 products were sold in a kit called , the Baby Blanket Sun Smart Survival Kit:, Baby Blanket Tend Scalps SPF 45, Baby Blanket Sunscreen Spray SPF 45, Baby Blanket Faces Sunblock SPF 45, Baby Blanket Sunblankie Towelette SPF 45

DIN, NPN, DIN-HIM

DIN 0246707

Dosage form

Lotion, wipe or spray

Strength

  • Not applicable

Lot or serial number

All lots

Companies

Recalling Firm
Zellers
8925 Torbram Rd.
Brampton Ontario
Canada L6T 4G1
Marketing Authorization Holder
Mercer Group Ltd. (Childrens Healthcare Research Group)
254 Hornbine Rd.
Rehoboth Massachusetts
United states ÉTATS-UNIS 02769