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Picato gel recalled over concerns of skin malignancy

By Isabel Shaw

27 Jan 2020

The manufacturer LEO laboratories LTD (T/A LEO Pharma) has today (27 January) recalled all unexpired stock of Picato gel over fears that it may cause skin malignancy. 

The actinic keratosis treatment is also being recalled due to the suspension of the marketing authorisation of Picato, according to the Medicines and Healthcare Regulatory Agency (MHRA).

Pharmacists have been advised to stop supplying the gel immediately and quarantine all remaining stock and return to the supplier, the MHRA said today.

They have also been advised to consider other treatment options for patients, and to urge those who have recently been prescribed Picato be vigilant for any skin lesions developing and to seek medical advice promptly should any occur.

The affected batches are:

Picato 150 mcg/g gel 

Picato 500 mcg/g gel 

Batch NumberExpiry DatePack SizeFirst Distributed
A69570AJan-203 x 0.47g tubes18-Apr-18
A69570BJan-203 x 0.47g tubes06-Jun-18
A72947AFeb-203 x 0.47g tubes06-Jun-18
A75024AApr-203 x 0.47g tubes18-Jul-18
A78808AMay-203 x 0.47g tubes05-Sep-18
A80602BJun-203 x 0.47g tubes12-Sep-18
A80602AJun-203 x 0.47g tubes12-Sep-18
A89440ANov-203 x 0.47g tubes22-Jan-19
A92248ADec-203 x 0.47g tubes11-Feb-19
A98938AMar-213 x 0.47g tubes16-May-19
C01098AApr-213 x 0.47g tubes24-Jun-19
C10894AAug-213 x 0.47g tubes22-Oct-19
C14179AOct-213 x 0.47g tubes06-Dec-19
A76669AApr-202 x 0.47g tubes22-Aug-18
A88113AOct-202 x 0.47g tubes11-Dec-18
A98419AMar-212 x 0.47g tubes16-May-19
C03413AMay-212 x 0.47g tubes29-Aug-19
C11902ASep-212 x 0.47g tubes08-Nov-19

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