Picato gel recalled over concerns of skin malignancy

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 Number	Expiry Date	Pack Size	First Distributed
A69570A	Jan-20	3 x 0.47g tubes	18-Apr-18
A69570B	Jan-20	3 x 0.47g tubes	06-Jun-18
A72947A	Feb-20	3 x 0.47g tubes	06-Jun-18
A75024A	Apr-20	3 x 0.47g tubes	18-Jul-18
A78808A	May-20	3 x 0.47g tubes	05-Sep-18
A80602B	Jun-20	3 x 0.47g tubes	12-Sep-18
A80602A	Jun-20	3 x 0.47g tubes	12-Sep-18
A89440A	Nov-20	3 x 0.47g tubes	22-Jan-19
A92248A	Dec-20	3 x 0.47g tubes	11-Feb-19
A98938A	Mar-21	3 x 0.47g tubes	16-May-19
C01098A	Apr-21	3 x 0.47g tubes	24-Jun-19
C10894A	Aug-21	3 x 0.47g tubes	22-Oct-19
C14179A	Oct-21	3 x 0.47g tubes	06-Dec-19
A76669A	Apr-20	2 x 0.47g tubes	22-Aug-18
A88113A	Oct-20	2 x 0.47g tubes	11-Dec-18
A98419A	Mar-21	2 x 0.47g tubes	16-May-19
C03413A	May-21	2 x 0.47g tubes	29-Aug-19
C11902A	Sep-21	2 x 0.47g tubes	08-Nov-19