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Oncolyn (March 24, 2006)
- Starting date:
- March 24, 2006
- Posting date:
- April 17, 2006
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-2006A77
Reason
Health Hazard Evaluation conducted by NHPD concluded the sale of this product is a Type II health risk due to the health claims for the treatment of cancer which are associated with the product as well as the implied claim of the brand name "Oncolyn". Furthermore, the product contains undeclared hawthorn extract with no label warnings contraindicating the product's use by pregnant women, and by those with cardiac conditions and/or taking cardiac drugs.
Depth of distribution
Distribution to wholesalers, retail as well as internet sales; also exported.
Affected products
Oncolyn
DIN, NPN, DIN-HIM
No market authorization
Dosage form
Tablet
Strength
- 750 mg
Lot or serial number
All lots
Companies
- Recalling Firm
- Sante International Inc.
111 West Second Street
Jamestown New York
United states ETATS-UNIS 14701
- Marketing Authorization Holder
- Not Applicable
- Date modified: