Archived - Recall of Ventolin® Diskus® / Serevent® Diskus® / Flovent® Diskus®

Important Safety Information Regarding the
Recall of Ventolin^® Diskus^® / Serevent^® Diskus^® / Flovent^® Diskus^®

November 10, 2003

Dear Doctor:

GlaxoSmithKline Inc. (GSK) has identified that a small number of multi-dose powder inhalation devices (Diskus^®) in certain lots of Ventolin Diskus/ Serevent Diskus/ Flovent Diskus may not function properly and that individuals may not receive a full or any dose of the drug. This could mean that a patient would not receive the medicine they require to control their asthma and/or Chronic Obstructive Pulmonary Disease (COPD). Patient safety is our first concern and after consultation with Health Canada, GSK is undertaking a recall of affected lots.

The overall risk to patients is low. The likelihood of a patient receiving a faulty Diskus inhalation device is very low as only a limited number of inhalation devices were affected (less than 0.18%). GSK has conducted a thorough investigation and appropriate corrective action has been taken.

Health Canada and GSK will be posting a warning to patients on their websites and through a public advisory. Patients are advised to check the lot number of their Serevent Diskus, Flovent Diskus or Ventolin Diskus, which is printed on the circular label on top of the Diskus unit. Patients with affected lots will be advised to return the DISKUS inhalation device to their local pharmacy where they will be issued a replacement Diskus inhalation device. Please note that Advair Diskus is NOT AFFECTED.

All pharmacists are receiving a comprehensive communication regarding affected Diskus lots in order to address the recall. Please call your local pharmacist if you have any specific questions regarding affected lots.

Some lots of physician samples of Flovent Diskus and Serevent Diskus may also be affected. As a result, please return any Diskus samples in your inventory from the following list:

Please return all affected samples immediately marked as "Recalled Material - Not For Use" via Purolator Collect. Please contact at 1-800-387-3027 and quote account # 7354960 and request package pick up. Please send your return to the following address:

Central Distribution Centre
GlaxoSmithKline Inc.
11 Rimini Mews
Mississauga, Ontario L5N 4K1

Health care professionals are asked to report any suspected adverse events associated with the use of these products directly to GSK using the following contact information:

GlaxoSmithKline Inc.
7333 Mississauga Road N
Mississauga, Ontario
L5N 6L4
Tel: 1-800-387-7374

Should you require any additional information please contact GSK Customer Service at 1-800-387-7374. Thank you in advance for your support in this matter.

Sincerely yours,

original signed by

Anne Phillips, M.D., FRCPC
Vice President, Research & Development and Chief Medical Officer
GlaxoSmithKline Inc.

^®Ventolin Diskus, Flovent Diskus, Serevent Diskus and Advair Diskus are registered trademarks, used under license by GlaxoSmithKline Inc.

Any suspected adverse incident can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
Health Canada
Address Locator: 0201C2
Ottawa, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.