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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