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Health product recall

Germi-Stat Prep Gel

Starting date:
July 31, 2013
Posting date:
August 16, 2013
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-35085

Recalled products

  1. Germi-Stat Prep Gel

Reason

Product does not meet assay specification for chlorhexidine gluconate at 36-month time-point.

Depth of distribution

Wholesalers across Canada

Affected products

A. Germi-Stat Prep Gel

DIN, NPN, DIN-HIM
DIN 02241528
Dosage form

Liquid

Strength
  • Chlorhexidine Gluconate 0.5%
  • Isopropyl Alcohol 70%
Lot or serial number
  • 00983
  • 01045
  • 01122
Companies
Recalling Firm
Germiphene Corporation
1379 Colborne Street East
Brantford
N3T 5M1
Ontario
CANADA
Marketing Authorization Holder
Germiphene Corporation
1379 Colborne Street East
Brantford
N3T 5M1
Ontario
CANADA

Date modified: