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APO-Risperidone (2015-06-03)

Starting date:
June 3, 2015
Posting date:
June 4, 2015
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-53691

Recalled Products

APO-Risperidone

Reason

Apotex initiated recall of one lot due to out of specification result for an unidentified impurity.

Depth of distribution

Wholesale, Distributor

Affected products

APO-Risperidone

DIN, NPN, DIN-HIM
DIN 02282178
Dosage form

Tablet

Strength

Risperidone 4.0 mg

Lot or serial number

KM3974

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