Archived – Steripaste Medicated Paste Bandages

Starting date:

November 14, 2007

Posting date:

November 14, 2007

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Microbial Hazard, Labelling and Packaging, Unauthorized products

Audience:

General Public

Identification number:

RA-12000277

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Source of alert

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)

Product name

Steripaste Medicated Paste Bandages, batch numbers: 07085930, 07085932, 07085673

Manufacturer / Place of origin

Medlock Medical Ltd., U.K.

Product description

Steripaste Medicated Paste Bandages are over-the-counter bandages containing zinc oxide used for the treatment of ulcers, particularly chronic leg ulcers.

Reason for warning

Medlock Medical Ltd. in the U.K. is recalling Steripaste Medicated Paste Bandages, batch numbers 07085930, 07085932 and 07085673 due to failed pouch seals that pose a risk of microbial contamination.

Possible side effects

This product may not be sterile so there is a possibility the bandage may cause a wound infection.

What you should do

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

Report a health or safety concern

• Call toll-free at 1-866-234-2345.
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

Images

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