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Health product recall

Sodium Chloride Injection USP 23.4% (2016-07-05)

Starting date:
July 5, 2016
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-59316

Affected products

A. Sodium Chloride Injection USP 23.4%

Reason

Out of specification result for pH during stability testing.

Depth of distribution

Retailers across Canada

Affected products

A. Sodium Chloride Injection USP 23.4%

DIN, NPN, DIN-HIM

DIN 00402230

Dosage form

Solution

Strength

234 mg/mL

Lot or serial number

"4D603

4F660

4F675

4K771

4L796

5A864

5B889

5C921

5D965

5F016

"

Companies
Recalling Firm

Omega Laboratories Ltd. 11177 Hamon Montreal, Quebec H3M 3E4

Marketing Authorization Holder

Omega Laboratories Ltd. 11177 Hamon Montreal, Quebec H3M 3E4