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Health product recall

Apo-Risperidone (2015-10-06)

Starting date:
October 6, 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-55308

Affected Products

Apo-Risperidone

Reason

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

Affected products

Apo-Risperidone

DIN, NPN, DIN-HIM
DIN 02280396
Dosage form

Solution

Strength

1 mg/ml

Lot or serial number

KV2311

Companies
Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
380 Elgin Mills Road East
Richmond Hill
L4C 5H2
Ontario
CANADA

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