Imatinib 400mg Capsules (3 x 10) PL 36390/0180 : Company-led Drug Alert

Cipla (EU) Limited has informed MHRA that there is an error on the Patient Information Leaflet (PIL) for the above product: the dosage information for the indication CML is incorrect

• From: Medicines and Healthcare products Regulatory Agency
• Published: 21 September 2018

• Message type: Medicines recall/notification
• Medical specialty: Haematology and oncology
• Issued: 21 September 2018

Product information

CLDA number

CLDA (18)A/08

MDR number

MDR 43-09/18

Company name

Cipla (EU) Ltd

Product description

Imatinib 400mg Capsules (3 x 10) PL 36390/0180

Batch number/expiry

Batch Number	Expiry Date
GJ80583	April 2020

Brief description of the problem

Cipla (EU) Limited has informed MHRA that there is an error on the Patient Information Leaflet (PIL) for the above product: the dosage information for the indication CML is incorrect

Action

Pharmacists are asked to remove the defective PIL from affected cartons before dispensing and provide a copy of the correct PIL

Please ensure that existing patients are taking the correct dose and provide a copy of the correct PIL if necessary.

Company contact for medical information enquiries:

Cipla (EU) Ltd

Tel: 07826544512 or 07876612672

Email: Sabrina.Ebu@Cipla.com or Prashant.Shirode@Cipla.com

Published 21 September 2018