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Medicine recalls

 
Canada: Leo Pharma Canada Inc. Product Recall
 
Health Canada announces that Leo Pharma Canada Inc. is recalling the following products from wholesalers, retailers and pharmacy:
- Picato (ingenol mebutate) 0.015% Topical Gel (lot number: A92594A, A98939A and C09552A)
- Picato (ingenol Mebutate) 0.05% Topical Gel (lot number: A95625A and C03414A)

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.

Please refer to the following website in Health Canada for details: http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74261r-eng.php

In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 19 Oct 2019, with the latest update posted on 28 Oct 2020.

Ends/Wednesday, Nov 4, 2020
Issued at HKT 15:00
 
Related Information:
Canada: PICATO (ingenol mebutate gel, 0.015% and 0.05%): Product withdrawal in C... Posted 2020-10-28
Canada: Summary Safety Review: Picato (ingenol mebutate): Assessing the Potentia... Posted 2020-07-03
European Union: Risks of Picato for actinic keratosis outweigh benefits Posted 2020-05-02
European Union: EMA review of Picato concludes medicine’s risks outweigh its ben... Posted 2020-04-18
The United Kingdom: Ingenol mebutate gel (Picato▼): suspension of the licence du... Posted 2020-02-13
The United Kingdom: Class 2 Medicines Recall: LEO Laboratories Ltd, Picato 150 m... Posted 2020-01-29
European Union: EMA suspends Picato as a precaution while review of skin cancer ... Posted 2020-01-18
The United Kingdom: Ingenol mebutate gel (Picato): increased incidence of skin t... Posted 2019-10-19
 
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