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Apo-Risperidone (2014-05-12)
- Starting date:
- May 12, 2014
- Posting date:
- May 22, 2014
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-39571
Recalled Products
Apo-Risperidone
Reason
Out of Specification results obtained for an impurity at the 21 and 15 month stability timepoint for batches KE0753 and KH5308 respectively.
Depth of distribution
Wholesalers/Distributors: Domestic and International
Affected products
Apo-Risperidone
DIN, NPN, DIN-HIM
DIN 02280396
Dosage form
Solution
Strength
1 mg/mL
Lot or serial number
KE0753 - 30 mL
KH5308 - 100 mL
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA