Class 2 Medicines Recall: Seretide Accuhaler 50 microgram/250 microgram/dose inhalation powder, pre-dispensed

Glaxo Wellcome UK Limited is recalling one lot of Seretide Accuhaler 50/250mcg because a manufacturing issue has resulted in a small number of units not delivering the full number of doses. (EL (18) A/04)

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

• Message type: Medicines recall/notification
• Medical specialty: Anaesthetics, Cardiology, Care home staff, Cosmetic surgery, Critical care, Dentistry, General practice, General surgery, Haematology and oncology, Infection prevention, Obstetrics and gynaecology, Ophthalmology, Orthopaedics, Paediatrics, Pathology, Pharmacy, Physiotherapy and occupational therapy, Radiology, Renal medicine, Theatre practitioners, Urology, Vascular and cardiac surgery
• Issued: 21 February 2018

Product information

MDR number

MDR 61-02/18

Company name

Glaxo Wellcome UK Ltd

Product description

Seretide Accuhaler 50 microgram/250 microgram/dose inhalation powder, pre-dispensed

(Salmeterol/Fluticasone Propionate)

PL number

PL 10949/0315

Lot number/expiry

• Lot Number: 5K8W
• Expiry Date: 04-2019
• Pack Size: 1 x 60 doses
• First Distributed: 29 August 2017

Brief description of the problem

Glaxo Wellcome UK Limited is recalling the above Lot of Seretide Accuhaler 50/250mcg because a manufacturing issue with this Lot has been identified which has resulted in a small number of units not delivering the full number of doses.

Please note, this is not a patient level recall.

Advice for healthcare professionals

Please quarantine any remaining stock of this Lot and return to the original supplier for credit. The location of Lot number and expiry is as shown in the images in the document below.

Advice for wholesalers

Quarantine any remaining stock of this Lot and return to the original supplier for credit.

Medical information enquiries

Please contact GSK via customercontactuk@gsk.com, Live Chat facility or by calling 0800 221 441 (option 4).

Stock enquiries

please refer to the GSK website or contact 0800 221 441 (option 1).

Download document

Seretide Accuhaler EL (18) A/04

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to relevant clinics, hospitals, mental health trusts, general practitioners and community pharmacists for information.

Published 21 February 2018