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Apo-Sibutramine (November 12, 2010)

Report a Concern
Starting date:
November 12, 2010
Posting date:
December 06, 2010
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Unacceptable risk to health
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-2010A259

Reason

Results from the Sibutramine Cardiovascular OUTcome (SCOUT) Trial suggested an increased risk of serious cardiovascular events associated with sibutramine use in patients with heart problems.

Depth of distribution

Various distributor, wholesale, and retail level distribution across Canada.

Affected products

Apo-Sibutramine

DIN, NPN, DIN-HIM

DIN 02337614

Dosage form

Capsule

Strength

  • 10 mg

Lot or serial number

JK1251, JK7146, JK7150

Companies

Recalling Firm
Apotex Inc
150 Signet Drive,
Toronto Ontario
Canada M9L 1T9
Marketing Authorization Holder
Apotex Inc
150 Signet Drive,
Toronto Ontario
Canada M9L 1T9