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Health professional risk communication

Archived - Product Recall Notice for Ventolin® Diskus® / Flovent® Diskus® / Serevent® Diskus® Inhalation Devices

Starting date:
November 10, 2003
Posting date:
November 18, 2003
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Audience:
Healthcare Professionals
Identification number:
RA-17000490

This is duplicated text of a letter from GlaxoSmithKline Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

[Text of letter begins]

Important Safety Information Regarding The
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

 

Product/Strength
Product/Strength Size DIN UPS Loc# Expiry Date Date of 1st Sale
VENTOLIN® DISKUS®
200mcg 60 dose 02243115 0 62021 23573 1 073 April 2004 Aug. 22 2002
081 May 2004
094 September 2004
105 November 2004
FLOVENT® DISKUS®
50mcg 60 dose 02237244 0 62021 24650 8 122 December 2003 Dec. 6, 2002
138 May 2004
146 July 2004
100mcg 60 dose 02237245 0 62021 24725 3 346 January 2004 Jan. 10, 2003
397 April 2004
250mcg 60 dose 02237246 0 62021 24665 2 305 December 2003 Oct. 15, 2002
325 Mars 2004
347 April 2004
354 April 2004
356 May 2004
360 May 2004
375 July 2004
500mcg 60 dose 02237247 0 62021 24670 6 579 December 2003 Dec. 19, 2002
600 May 2004
605 May 2004
608 May 2004
614 June 2004
615 June 2004
SEREVENT® DISKUS®
50mcg 60 dose 02231129 0 62021 25330 8 491 June 2004 Sept. 20, 2002
496 June 2004
527 September 2004
537 November 2004
550 December 2004
556 January 2005
 

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

[Text of letter ends]

 

Archived - Diskus Recall Return Form

2003-11-18 | Health products

Advisory

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