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:
2020-11-03
Summary
-
Product:
A. Picato 0.015% Topical GelB. 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