PEGETRON REDIPEN (peginterferon alfa-2b) – Recall of Triad Group Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks – For the Public

Starting date:

February 3, 2011

Posting date:

February 3, 2011

Type of communication:

Public Communication

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000981

This is duplicated text of a letter from Merck Canada Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication

Health Canada Endorsed Important Safety Information on PEGETRON REDIPEN (peginterferon alfa-2b)

February 3, 2011

Subject: Important information regarding PEGETRON^® REDIPEN^® (peginterferon alfa-2b Powder for Solution in Single Dose Delivery System: 80 mcg per 0.5 mL, 100 mcg per 0.5 mL, 120 mcg per 0.5 mL and 150 mcg per 0.5 mL)

Merck Canada Inc., in consultation with Health Canada, would like to inform you of important information regarding the use of PEGETRON^® REDIPEN^®. The alcohol prep pads that are included in your package of PEGETRON^® REDIPEN^® have been voluntarily recalled by the manufacturer, the Triad Group, due to potential microbial contamination. The alcohol swabs are labelled ALCO-PREP^® Pre-injection cleansing swab.

• You should continue to use your PEGETRON^® REDIPEN^® injection and capsules as directed by your health care professional.
• Do NOT use the ALCO-PREP^® Pre-injection cleansing swab, that are in your package of PEGETRON^® REDIPEN^®.  
• Alternate alcohol pads are available for purchase at your local pharmacy or you can use sterile gauze pads with bottled isopropyl alcohol (70%).
• You are requested to report signs of injection site infections (such as redness, warmth, pain and/or swelling) to your healthcare professional.

Upon discussion and agreement with Health Canada, Merck Canada Inc. will begin packaging orders with suitable alternative alcohol prep pads.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients using PEGETRON^® should be reported to Merck Pharmacovigilance or Health Canada as follows.

Merck Canada Inc., Pharmacovigilance

16711 Trans-Canada Hwy.

Kirkland, Quebec H9H 3L1

Fax: 1-800-369-3090

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at MedEffect^TM Canada
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    
    Health Canada
    
    Postal Locator 0701E
    
    Ottawa, Ontario  K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please contact Health Canada at:

Health Product and Food Branch Inspectorate (HPFBI)

E-mail: DCVIU_UVCEM@hc-sc.gc.ca

Telephone: 1-800-267-9675

Fax: 1-613-946-5636

If you have any questions regarding this important information, please contact our Customer Services at 1-800-361-6550. For medical inquiries, please contact us at 1-800-567-2594.

original signed by

Michel Cimon, MD, MPH

Medical Executive Director, Medical Affairs

PEGETRON^® Registered trademark of Schering-Plough Canada Ltd. Used under license.

REDIPEN^® Registered trademark of Merck Canada Inc.

ALCO-PREP^® : property of the owner.