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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