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