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Rexall Melatonin (2013-10-02)

Report a Concern
Starting date:
October 2, 2013
Posting date:
October 18, 2013
Type of communication:
Drug Recall
Subcategory:
Natural health products
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-36297

Recalled Products

Rexall Melatonin 

Reason

The product is being recalled due to an error in the French text.  The label incorrectly states:

"Consulter un professionnel de la santé si vous souffrez de maladies hormonales, de diabète, de maladies hépatiques ou rénale, d’infirmité motrice cérébrale, D’ATTAQUES, de migraine, de dépression ou d’hypertension, ou si vous prenez des médicaments pour la pression artérielle ou des sédatifs hypnotiques" 

The correct text is:

"Consulter un professionnel de la santé si vous souffrez de maladies hormonales, de diabète, de maladies hépatiques ou rénale, d’infirmité motrice cérébrale, DE CRISES D’EPILEPSIE, de migraine, de dépression ou d’hypertension, ou si vous prenez des médicaments pour la pression artérielle ou des sédatifs hypnotiques" 

Depth of distribution

Distributed to the retail level.  Nationally in Canada only.

Affected products

Rexall Melatonin 

DIN, NPN, DIN-HIM
NPN 80000851
Dosage form

Tablet

Strength
  • Melatonin, 3 mg
Lot or serial number
  • 1J0382L2U
Companies
Recalling Firm
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA