Health product recall

Keytruda (2019-04-23)

Starting date:
April 23, 2019
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-69734

Last updated: 2019-04-26

Summary

  • Product:
    Keytruda for IV infusion 4mL single use vial

Reason

Affected lot may be missing the product name and/or dosage on the label.  Only the units that have missing information are being recalled.

Depth of distribution

Healthcare establishments

Affected products

Keytruda for IV infusion 4mL single use vial

DIN, NPN, DIN-HIM

DIN 02456869

Dosage form

Liquid

Strength

Pembrolizumab 25 mg/mL

Lot or serial number

8302611002

Companies

Recalling Firm

Merck Canada

16750 Trans Canada HWY

Kirkland

H9H 4M7

Quebec

CANADA

Marketing Authorization Holder

Merck Canada

16750 Trans Canada HWY

Kirkland

H9H 4M7

Quebec

CANADA