Archived - FiberChoice plus Multivitamins

Starting date:

April 24, 2007

Posting date:

April 24, 2007

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Allergy Information, Undeclared Substance

Audience:

General Public

Identification number:

RA-12000312

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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

GlaxoSmithKline (GSK)

Product name

FiberChoice plus Multivitamins

Manufacturer / Place of origin

GlaxoSmithKline (GSK), United States

Product description

FiberChoice plus Multivitamins are marketed as a fibre supplement in the U.S. The product is sold in a multi-coloured plastic bottle, each bottle containing 90 tablets (16 oz.)

Reason for warning

GlaxoSmithKline recalled FiberChoice plus Multivitamins after the product was found to be contaminated with fish gelatin, a known allergen that can cause life-threatening reactions in some sensitive individuals or those with known or previously unknown fish allergies. Fish gelatin is not declared as an ingredient on the product label.

Possible side effects

The risk of serious allergic reactions is more likely in consumers with a known history of fish or seafood allergies and those with asthma.

The side effects can vary from minor symptoms (e.g. itching, nausea) to serious reactions involving the gastrointestinal tract (e.g. abdominal pain, vomiting, diarrhea), respiratory tract (e.g. breathing difficulty) and anaphylaxis (life-threatening allergic reaction).

Consumers should avoid or discontinue use of this product immediately. Consumers who suspect an adverse reaction should consult their health practitioner as soon as possible.

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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