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Health product recall

Sodium Chloride Injection USP 0.9%

Starting date:
February 21, 2013
Posting date:
March 19, 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-25893

Recalled Products

  1. Sodium Chloride Injection USP 0.9 %

Reason

Out-of-specification pH results (pH above average level of 4.5-7) during sample stability testing.

Depth of distribution

Hospitals, pharmacies and health centers and social services in Quebec.

Affected products

A. Sodium Chloride Injection USP 0.9%

DIN, NPN, DIN-HIM
DIN 02350351
Dosage form
  • Injectable Solution
Strength
  • 0.9%
Lot or serial number
  • 1C02
  • 1C03
  • 1C04
  • 1C05
  • 1C06
  • 1E03
  • 1E04
  • 1E07
  • 1F03
  • 1F05
  • 1G01
  • 1H01
  • 1H03
  • 1K01
  • 1K04
  • 1L02
  • 1L03
  • 1N02
  • 1N03
  • 2A02
  • 2A03
  • 2B05
Companies
Recalling Firm
Laboratoires Sterigen Inc.
242 St-Cyrille Street West
Upton
J0H 2E0
Quebec
CANADA
Marketing Authorization Holder
Laboratoires Sterigen Inc.
242 St-Cyrille Street West
Upton
J0H 2E0
Quebec
CANADA