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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
- Date modified: