NebuChamber Device (Inhalation Aid) - Recall

DRUG ALERT

Class 2 recall

Action within 48 hours

Pharmacy or equivalent level recall

31 March 2009 EL (09)A/09 Our ref: MDR 62-03/09

Dear Healthcare Professional,

AstraZeneca UK Ltd

NebuChamber Device (Inhalation Aid)

(Recall of all stock - no batch number is quoted on the device)

AstraZeneca and the MHRA Devices division have asked DMRC to distribute the enclosed information concerning a defective medical device which is widely prescribed and distributed through community pharmacies, clinics and hospitals. All stock of the NebuChamber is being recalled from pharmacies, hospitals and distributors.

This product is an inhalation aid intended to be used with Pulmicort® pressurised metered dose inhaler manufactured by AstraZeneca. It consists of a metal spacer and mouthpiece and a facemask can be used in some patients.

NebuChamber contains a one-way valve and it is essential that the mouthpiece is attached to the spacer in the correct direction. The product is normally manufactured to achieve this. AstraZeneca has received reports that the mouthpiece can sometimes be attached in the incorrect direction which is clinically significant.

AstraZeneca is also requesting Pharmacists and/or Doctors to contact known patients who have received a NebuChamber device and arrange for a device other than NebuChamber to be provided or switch the patient to an alternative medication.

If an alternative device or treatment is not available or suitable, healthcare professionals are asked to emphasise the importance of correct assembly. The frosted end of the mouthpiece must be attached to the spacer.

No new patients should be offered NebuChamber at present. AstraZeneca is unable to supply acceptable replacement devices for the immediate future. Replacement stocks will be made available as quickly as possible. We note that this device does not bear batch numbers. When acceptable stock is distributed in the future we envisage there will be advertisements in the trade press to inform users and explain how to identify the new acceptable devices.

Please return all NebuChamber stocks to the original supplier (either AAH or Unichem).

For medical information enquiries, please telephone AstraZeneca Medical Information on 01582 836836.

Recipients of this Drug Alert should bring this information to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to bring this information to the attention of relevant clinics, General Practitioners and Community Pharmacists by copy of this letter.

Yours faithfully

Ian Holloway

MHRA DMRC Manager

MHRA Distribution (further recipients by cascade):

Regional Contacts for NHS Trusts and Provider Units

Chief Pharmacists: England, Scotland, Wales, Northern Ireland

Prison Health Policy Unit (DH)

Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar

Special Hospitals

Healthcare Commission for distribution to Independent Health Care Establishments

Primary Care Trusts (England)