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Health product recall

Allerject 0.3 mg / 0.3 mL (2015-10-28)

Starting date:
October 28, 2015
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-55690

Affected Products

Allerject 0.3 mg / 0.3 mL

Reason

Potential device defect affecting delivery of drug to patient.

Depth of distribution

Wholesalers/distributors, pharmacies, hospitals and health care professionals across Canada.

Affected products

Allerject 0.3 mg / 0.3 mL

DIN, NPN, DIN-HIM

DIN 2382067

Dosage form

Sterile auto-injector

Strength

Epinephrine 0.3 mg/ 0.3 mL

Lot or serial number

3060874

3028224

2921710

2857511

2692161

2620196

2506435

2440696

2299566

2328062

2265542

2052154

2081289

3028226

2922463

2852090

2692164

2620199

2506445

2506446

2440699

2265550

2265551

2081292

2081293

Companies
Recalling Firm

Sanofi Aventis (Canada) Inc.

2905 Louis R. Renaud Place

Laval

H7V 0A3

Quebec

CANADA

Marketing Authorization Holder

Sanofi Aventis (Canada) Inc.

2905 Louis R. Renaud Place

Laval

H7V 0A3

Quebec

CANADA