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Rexall Melatonin (2013-10-02)
- 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 80000851Dosage 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