The Medicines and Health products Regulatory Agency (MHRA) today issued a class 2 medicines recall for Picato 150 mcg/g and 500 mcg/g gel.

LEO Pharma is recalling all unexpired stock of the products from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy.

This is following the suspension of the marketing authorisation of Picato (ingenol mebutate), while the investigations are ongoing.

“Stop prescribing Picato and consider other treatment options as appropriate. For patients who have recently been prescribed Picato, advise patients to be vigilant for any skin lesions developing and to seek medical advice promptly should any occur,” the government agency advised healthcare professionals.

Pharmacists are asked to stop supplying the products immediately, quarantine remaining stock and return it to the supplier using the approved process.

Healthcare professionals are also asked to report any suspected adverse reactions via Yellow Card Scheme www.mhra.gov.uk/yellowcard or MHRA Yellow Card app.

Product details:

Product Marketing Authorisation Number
Picato 150 mcg/g gel ▼ EU/1/12/796/001
Picato 500 mcg/g gel ▼ EU/1/12/796/002

 

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

 

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