This page has been archived on the Web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.

Archived

This page has been archived on the Web.

Health product recall

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

Date modified: