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Health product recall

Hycodan Tablets (2014-03-03)

Starting date:
March 3, 2014
Posting date:
March 21, 2014
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-38331

Recalled products

Hycodan Tablets

Reason

Lot KNPP did not meet dissolution specifications at the 12-month stability test point, and there is a risk that lot FSTN may not meet dissolution specifications at the end of shelf-life.

Depth of distribution

Wholesalers across Canada

Affected products

A. Hycodan Tablets

DIN, NPN, DIN-HIM
DIN 01916599
Dosage form

Tablets

Strength
  • 5 mg
Lot or serial number
  • KNPP
  • FSTN
Companies
Recalling Firm
Bristol-Myers Squibb Canada
2344 Alfred-Nobel, Suite 300
Saint-Laurent
H4S 0A4
Quebec
CANADA
Marketing Authorization Holder
Bristol-Myers Squibb Canada
2344 Alfred-Nobel, Suite 300
Saint-Laurent
H4S 0A4
Quebec
CANADA

Date modified: