Hoffman-La Roche Herceptin Product Recall (2020-06-27)

Starting date:
June 27, 2020
Type of communication:
Drug Recall
Subcategory:
Drugs, Biologic/vaccine
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73443

Last updated:

Summary

  • Product: A. Perjeta-Herceptin Kit Powder for solution (Combo pack); B. Herceptin 440 mg/vial powder for solution

Reason

Affected lots may contain the presence of glass particulates.

Depth of distribution

Wholesalers, Healthcare establishments

Affected products

A. Perjeta-Herceptin Kit Powder for solution (Combo pack)

DIN, NPN, DIN-HIM

DIN 02405024

Dosage form

Kit, Powder For Solution, Solution

Strength

Pertuzumab 420 mg/14 mL
Trastuzumab 440 mg/vial

Lot or serial number

H0379B19

Companies

Recalling Firm
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga
L5N 5M8
Ontario
CANADA
Marketing Authorization Holder
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga
L5N 5M8
Ontario
CANADA

B. Herceptin 440 mg/vial powder for solution

DIN, NPN, DIN-HIM

DIN 02240692

Dosage form

Powder for solution

Strength

Trastuzumab 440 mg/vial

Lot or serial number

N3928B01

Companies

Recalling Firm
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga
L5N 5M8
Ontario
CANADA
Marketing Authorization Holder
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga
L5N 5M8
Ontario
CANADA