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Health product recall

Quetiapine 25 mg

Starting date:
May 17, 2013
Posting date:
June 3, 2013
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety, Contamination
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-33871

Recalled Products

  1. Quetiapine 25 mg

Reason

Potential cross-contamination of trace amounts of Clindamycin in Quetiapine Active Pharmaceutical Ingredient during the manufacturing process.

Depth of distribution

Distributed to wholesalers/pharmacies across Canada

Affected products

A. Quetiapine 25 mg

DIN, NPN, DIN-HIM
DIN 02353164
Dosage form
  • Tablet
Strength
  • 25 mg
Lot or serial number
  • All lots
Companies
Recalling Firm
Sanis Health Inc.
333 Champlain Street, Suite 102
Dieppe
E1A 1P2
New Brunswick
CANADA
Marketing Authorization Holder
Sanis Health Inc.
333 Champlain Street, Suite 102
Dieppe
E1A 1P2
New Brunswick
CANADA