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||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|