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Health product recall

Atropine sulfate injection (2015-06-23)

Starting date:
June 23, 2015
Posting date:
July 7, 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-54110

Recalled Products

  1. Atropine sulfate injection 0.5 mg / 5 mL
  2. Atropine sulfate injection 1 mg / 5 mL

Reason

Inaccurate dosing information on inner and outer labels.

Depth of distribution

Wholesalers and Hospitals

Affected products

A. Atropine sulfate injection 0.5 mg / 5 mL

DIN, NPN, DIN-HIM
DIN 02426269
Dosage form

Solution

Strength

Atropine Sulfate 0.5 mg / 5 mL

Lot or serial number
  • 6500565
Companies
Recalling Firm
BioSyvent Pharma Inc.
170 Attwell Drive, Suite 520
Toronto
M9W 5Z5
Ontario
CANADA
Marketing Authorization Holder
BioSyvent Pharma Inc.
170 Attwell Drive, Suite 520
Toronto
M9W 5Z5
Ontario
CANADA

B. Atropine sulfate injection 1 mg / 5 mL

DIN, NPN, DIN-HIM
DIN 02426277
Dosage form

Solution

Strength

Atropine Sulfate 1 mg / 5 mL

Lot or serial number
  • 6500580
Companies
Recalling Firm
BioSyvent Pharma Inc.
170 Attwell Drive, Suite 520
Toronto
M9W 5Z5
Ontario
CANADA
Marketing Authorization Holder
BioSyvent Pharma Inc.
170 Attwell Drive, Suite 520
Toronto
M9W 5Z5
Ontario
CANADA

Date modified: