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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