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Health product recall

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

Date modified: