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Health product recall

Novo-Risperidone (2014-05-06)

Starting date:
May 6, 2014
Posting date:
May 22, 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-39451

Recalled Products

Novo-Risperidone

Reason

The product was found to exceed impurity specifications for a known degradant during routine stability testing.

Depth of distribution

Retail level in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland, Nova Scotia, Ontario, Quebec and Saskatchewan.

Affected products

Novo-Risperidone

DIN, NPN, DIN-HIM
DIN 02264188
Dosage form

Tablets

Strength

0.5 mg

Lot or serial number

0010512
0020512
0110813

Companies
Recalling Firm
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA
Marketing Authorization Holder
Teva Canada Ltd.
30 Novopharm Court
Toronto
M1B 2K9
Ontario
CANADA

Date modified: