Class 2 Medicines Recall: Ventolin Accuhaler 200mcg (Salbutamol Sulfate)

Glaxo Wellcome UK is recalling two Lots of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units not delivering the full number of doses (EL (18) A/03)

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 59-02/18

Company name

Glaxo Wellcome UK Ltd

Product description

Ventolin Accuhaler 200mcg (Salbutamol Sulfate) PL 10949/0252

  • Lot Number: 786G
    • Expiry Date: 05-2019
    • Pack Size: 1 x 60 doses
    • First Distributed: 02-Oct-2017
  • Lot Number: 754P
    • Expiry Date: 05-2019
    • Pack Size: 1 x 60 doses
    • First Distributed: 31-Aug-2017

Brief description of the problem

Glaxo Wellcome UK Limited is recalling the above Lots of Ventolin Accuhaler 200mcg because a manufacturing issue with these Lots has been identified which has resulted in a small number of units not delivering the full number of doses.

Advice for healthcare professionals

Please:

  • quarantine any remaining stock of these Lots and return to the original supplier for credit
  • identify patients or carers who have received Ventolin Accuhalers since 31 August 2017
  • contact these patients or carers to notify them of this issue and ask them to check whether their Ventolin Accuhalers have Lot numbers 786G or 754P printed on the device and packaging. The location of Lot number and Expiry is as reflected in the images in the Class 2 Medicines Recall: Ventolin Accuhaler 200mcg (Salbutamol Sulfate) EL (18) A/03.
  • if the patient or carer has any Ventolin Accuhalers 200mcg from these Lots, they should be asked to return them to their pharmacy or their dispensing practice for replacement with a different Lot number.

Please provide replacement packs to patients at point of return, to ensure that affected patients are not left without a supply of their medicine.

Advice for wholesalers

  • Quarantine any remaining stock of these Lots and return to the original supplier for credit.

Advice for patients

  • If you have received any Ventolin Accuhalers 200mcg since 31 August 2017, check whether either of the Lot numbers 786G or 754P are printed on the device or any of the packaging.
  • The lot number appears on the bottom of the Ventolin Accuhaler cardboard package (four characters after the word ‘Lot) or in the centre of the device (similarly four characters after the word ‘Lot’)
  • If you have any Ventolin Accuhalers from these Lots, take them to your pharmacy or your dispensing practice and speak to a pharmacist who will provide a replacement.

Contact details

Medical information enquiries

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

Stock enquiries

Please refer to the GSK website or contact 0800 221441 (option 1).

Download document

Class 2 Medicines Recall: Ventolin Accuhaler 200mcg (Salbutamol Sulfate) EL (18) A/03

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, General Practitioners and Community Pharmacists.

Published 21 February 2018
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