Class 2 Medicines recall: Picato 150 mcg/g and 500 mcg/g gel (LEO Pharma)

Class 2 Medicines recall: Picato 150 mcg/g and 500 mcg/g gel (LEO Pharma)

January 27, 2020

Class 2 MHRA medicines recall – Picato 150 mcg/g and 500 mcg/g gel (LEO Pharma)

Drug alert number: EL (20)A/02

Date issued:27 January 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Picato 150 mcg/g and 500 mcg/g gel (LEO Pharma)

LEO Laboratories Ltd (T/A LEO Pharma) is recalling all unexpired stock of Picato Gel (ingenol mebutate) (listed below) from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy. The recall is a precautionary measure following the suspension of the marketing authorisation for Picato, while investigations are ongoing.

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 Mar-21 2 x 0.47g tubes 29-Aug-19
C11902A Sep-21 2 x 0.47g tubes 08-Nov-19

Advice for healthcare professionals
• Stop supplying the above products immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
• 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.

▼ Picato is subject to additional monitoring to allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Further information

Full drug alert can be viewed here.

Replacement stock of this product will not be available. Please contact your supplier/wholesaler for details on the returns process.

Credit for returned products must be obtained from the supplier from where the product was purchased. If you have any questions in regard to return of stock, then please contact your local Alliance Healthcare Service Centre Customer Services team.

For medical information enquiries contact LEO Pharma Medical Information Department 01844 347 333 and press 2 for Medical Information, or by email at medical-info.uk@leo-pharma.com.




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