This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
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