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Melatonin Extra Strength 5 mg (2015-05-11)
- Starting date:
- May 11, 2015
- Posting date:
- May 19, 2015
- Type of communication:
- Drug Recall
- Subcategory:
- Natural health products
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-53437
Recalled Products
Melatonin Extra Strength 5 mg
Reason
Labelling error. Product label incorrectly states "Recommended dosage (adults only): At or before bedtime, allow to dissolve under the tongue 1-2 tablets once daily or as directed by the physician". The tablet is intended to be swallowed, as the correct recommended dosage is time released and not sublingual.
Depth of distribution
Wholesalers, Retailers
Affected products
Melatonin Extra Strength 5 mg
DIN, NPN, DIN-HIM
NPN 80032969
Dosage form
Timed release, Tablets
Strength
Melatonin 5 mg
Lot or serial number
- 717975
- 719046
- 719047
Companies
- Recalling Firm
-
Factors Group of Nutritional Companies Inc.
1550 United Blvd.
Coquitlam
V3K 6Y7
British Columbia
CANADA
- Marketing Authorization Holder
-
WN Pharmaceuticals Ltd
2000 Brigantine Drive
Coquitlam
V3K 7B5
British Columbia
CANADA