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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

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