This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

Epipen Jr. (2017-03-31)

Starting date:
March 31, 2017
Posting date:
April 4, 2017
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-62924

Affected Products

A. Epipen Jr. (.15 mg)

B. Epipen (.3 mg)

Reason

Malfunction of the affected lots' auto-injector that may impact dispensing of the product

Depth of distribution

Retailers

Affected products

A. Epipen Jr. (.15 mg)

DIN, NPN, DIN-HIM

DIN 00578657

Dosage form

A. Sterile liquid for injection

Strength

A. 0.15 mg epinephrine

Lot or serial number

A. 5GR765

Companies
Recalling Firm

Pfizer Canada Inc.

17300 Trans-Canada Hwy.

Kirkland

H9J 2M5

Ontario

CANADA

Marketing Authorization Holder

Mylan Specialty LP

781 Chestnut Ridge Road

Morgantown

26504-4310

West Virginia

UNITED STATES



B. Epipen Jr. (.3 mg)

DIN, NPN, DIN-HIM

B. DIN 00509558

Dosage form

B. sterile liquid for injection

Strength

B. 0.3 mg epinephrine

Lot or serial number

B. 5GU763

Companies
Recalling Firm

Pfizer Canada Inc.

17300 Trans-Canada Hwy.

Kirkland

H9J 2M5

Ontario

CANADA

Marketing Authorization Holder

Mylan Specialty LP

781 Chestnut Ridge Road

Morgantown

26504-4310

West Virginia

UNITED STATES