Health Canada
www.hc-sc.gc.ca
Common menu bar links
Product Recall Notice for VENTOLIN® DISKUS®/ FLOVENT® DISKUS® / SEREVENT® DISKUS® Inhalation Devices
Date: 2003-11-18
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 27 K)Contact
BCANS Enquiries
The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties. Although MHPD, TPD and BGTD approve therapeutic products, MHPD, TPD and BGTD do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from GlaxoSmithKline Inc.
Contact the company for a copy of any references, attachments or enclosures.
PRODUCT RECALL NOTICE for VENTOLIN® DISKUS®/ FLOVENT® DISKUS® / SEREVENT® DISKUS® Inhalation Devices
***URGENT***
PRODUCT RECALL NOTICE
ATTENTION: All Pharmacists and Wholesalers
Date: November 10, 2003
Manufacturer: GlaxoSmithKline Inc. (GSK)
Product Description: VENTOLIN® DISKUS®/ FLOVENT® DISKUS®/ SEREVENT® DISKUS® Inhalation Devices
Reason for Recall:
GSK has identified that a small number of multi-dose dry powder inhalers (DISKUS®) in certain lots of VENTOLIN® DISKUS®/FLOVENT® DISKUS®/SEREVENT® DISKUS® may have a minor defect as a result of a fault in the manufacturing process. This manufacturing issue has been resolved. This defect could mean that a patient would not receive the medicine they require to control their asthma and/or COPD. The overall risk to patients is low as a very small number of DISKUS® inhalation devices are affected.
Class of Recall:
Level 1 - GSK will be issuing a public advisory to patients.
Special Instructions:
This selected lot recall does not affect any other VENTOLIN®, FLOVENT®, or SEREVENT® metered
dose or dry powder inhalers. That is, it does not affect VENTOLIN® HFA, VENTODISK® DISKHALER® ,
VENTOLIN® ROTAHALER®, FLOVENT® HFA, SEREVENT® MDI and SEREVENT® DISKHALER®.
Also note that ADVAIR® DISKUS® is not affected.
Note to Pharmacist:
Consumers and health care professionals are asked to report any suspected adverse events associated with the use of these products directly to
GSK or Health Canada using the following contact information: GlaxoSmithKline Inc.
7333 Mississauga Road N
Mississauga, Ontario L5N 6L4
Tel: 1-800-387-7374
Canadian Adverse Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
Ottawa, Ontario K1A 1B9
Toll free phone: 1-866-234-2345
Toll free fax: 1-866-678-6789
cadrmp@hc-sc.gc.ca
Return Procedure: All further distribution of the above lot numbers must cease. Please return all affected stock immediately marked as "Recalled Material - Not For Use" via Purolator Collect. Please contact Purolator 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
Credit Policy and Pharmacist Compensation:
All recalled stock will receive 100% credit based upon GSK's current manufacturer list price. GSK will compensate pharmacists directly involved
in this recall with a professional fee of $11.00 for each VENTOLIN DISKUS/FLOVENT DISKUS/SEREVENT DISKUS prescription returned and replaced.
To facilitate this process we ask that you complete the attached Recall Return Form and include it with your return. Please be advised that
recalled stock and pharmacist claims for professional fees will be accepted by GSK until December 12, 2003.
Please note: Prior to returning any product to us, we ask that you remove any patient information from each returned prescription.
Should you require additional information concerning the return of affected stock, please contact GSK Customer Service at 1-800-387-7374.
® VENTOLIN DISKUS, VENTOLIN HFA, VENTODISK, DISKHALER, VENTOLIN ROTAHALER, FLOVENT DISKUS, FLOVENT HFA, SEREVENT DISKUS, SEREVENT MDI, SEREVENT DISKHALER and ADVAIR DISKUS are registered trademarks, used under license by GlaxoSmithKline Inc.
WEB LINK to the
VENTOLIN® DISKUS® / FLOVENT® DISKUS® / SEREVENT® DISKUS®
RECALL RETURN FORM
