Archived – Product Recall Notice: Important Warning Regarding Diskus Inhalers – For the Public

November 12, 2003

MISSISSAUGA, Ontario (November 12, 2003)-- GlaxoSmithKline Inc., following discussions with Health Canada, would like to warn the Canadian public that certain lots of three products prescribed for the treatment of asthma and/or Chronic Obstructive Pulmonary Disease (COPD) - VENTOLIN^® DISKUS^®, FLOVENT^® DISKUS^® and SEREVENT^® DISKUS^® - are being recalled. There is a risk that a small number of these DISKUS inhalation devices used to deliver the drug may not function properly and that individuals may not receive a full or any dose of the drug. As patient safety is our first concern, GSK is undertaking a recall of affected lots.

This warning refers to certain lots of DISKUS inhalation devices purchased at a pharmacy or given out as a sample by a physician or clinic. Consumers should carefully check their DISKUS inhalation devices for affected lot numbers (listed below) or if uncertain seek assistance from their pharmacist. The lot number of each inhalation device is printed in the circular label in the centre of the DISKUS.

These products are prescribed for the treatment of asthma and/or COPD, which are serious illnesses. If patients do not receive a full therapeutic dose of these drugs, they may have increased symptoms, which could result in serious health consequences.

The recall has been initiated because there was a fault during the manufacturing process, which has since been resolved. The exact products, dosages, lot numbers and Drug Identification Numbers (DIN) are listed below. Only the DISKUS method of delivery for these drugs is involved in this recall. Metered dose inhalers (MDI), or the spray form, of these products are not affected by this manufacturing defect.

Please note that only certain lot numbers of these products are affected, as follows:

• VENTOLIN DISKUS 200mcg (DIN 02243115): lot numbers 073, 081, 094, and 105; expiring between April and November 2004.
• SEREVENT DISKUS 50mcg (DIN 02231129): lot numbers 491, 496, 527, 537, 550 and 556; expiring between June 2004 and January 2005.

The following FLOVENT DISKUS products:

• FLOVENT DISKUS 50mcg (DIN 02237244): lot numbers 122, 138 and 146; expiring between December 2003 and July 2004.
• FLOVENT DISKUS 100mcg (DIN 02237245): lot numbers 346 and 397; expiring between January and April 2004.
• FLOVENT DISKUS 250mcg (DIN 02237246): lot numbers 305, 325, 347, 354, 356, 360 and 375; expiring between December 2003 and July 2004.
• FLOVENT DISKUS 500mcg (DIN 02237247): lot numbers 579, 600, 605, 608, 614 and 615; expiring between December 2003 and June 2004.

As a precaution, consumers who have these DISKUS inhalation devices are advised to return the products to their pharmacist for replacement. Individuals who are experiencing increasing symptoms, or who are not responding to their medication, should consult with their physician as soon as possible.

This information may be obtained on the Canadian website of GlaxoSmithKline or on the website of the Therapeutic Products Directorate of Health Canada.

Consumers and healthcare professionals are asked to report any suspected adverse events associated with the use of these products directly to GSK.

GlaxoSmithKline Inc.

7333 Mississauga Road N

Mississauga, Ontario

L5N 6L4

Tel: 1-800-387-7374

Media Inquiries:

Corporate Communications

GlaxoSmithKline Inc.

(905) 819-3363

® VENTOLIN DISKUS, FLOVENT DISKUS and SEREVENT 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.