Leo Pharma Canada Inc. Product Recall (2020-10-26)

Starting date:
October 26, 2020
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74261

Last updated:

Summary

  • Product: A. Picato 0.015% Topical Gel B. Picato 0.05% Topical Gel

A. Picato 0.015% Topical Gel

B. Picato 0.05% Topical Gel

Reason

Following the review of safety and efficacy information, it was concluded that there may be a link between Picato and an increased risk of skin cancer.

Depth of distribution

Wholesalers, Retailers, Pharmacy

Affected products

Picato 0.015% Topical Gel

DIN, NPN, DIN-HIM

DIN 02400987

Dosage form

Gel

Strength

Ingenol Mebutate 0.015%

Lot or serial number

A92594A
A98939A
C09552A

Companies

Recalling Firm
Leo Pharma Canada Inc.
123 Commerce Valley Drive East, Suite 400
Thornhill
L3T 7W8
Ontario
CANADA
Marketing Authorization Holder
Leo Pharma Canada Inc.
123 Commerce Valley Drive East, Suite 400
Thornhill
L3T 7W8
Ontario
CANADA

Picato 0.05% Topical Gel

DIN, NPN, DIN-HIM

DIN 02400995

Dosage form

Gel

Strength

Ingenol Mebutate 0.05%

Lot or serial number

A95625A
C03414A

Companies

Recalling Firm
Leo Pharma Canada Inc.
123 Commerce Valley Drive East, Suite 400
Thornhill
L3T 7W8
Ontario
CANADA
Marketing Authorization Holder
Leo Pharma Canada Inc.
123 Commerce Valley Drive East, Suite 400
Thornhill
L3T 7W8
Ontario
CANADA