Foreign Product Alert: MONTALIN Jamu Pegal Linu Dan Asam Urat

Starting date:

February 7, 2014

Posting date:

February 7, 2014

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Source of alert:

Singapore Health Sciences Authority

Issue:

Undeclared Substance

Audience:

General Public

Identification number:

RA-37715

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Introduction

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

Affected product

• MONTALIN Jamu Pegal Linu Dan Asam Urat

MONTALIN Jamu Pegal Linu Dan Asam Urat

Product description

This product is promoted as Jamu (a form of traditional Indonesian herbal medicine) used for pain relief.

Hazard identified

The Singapore Health Sciences Authority warned consumers not to use this product after it was found to contain piroxicam and paracetamol, drug ingredients that were not declared on the label.

• Piroxicam is a prescription non-steroidal anti-inflammatory drug (NSAID) used to treat pain, fever and inflammation.
• Paracetamol, also known as acetaminophen, is an ingredient used in both non-prescription and prescription drugs to treat fever and pain.

Place of origin

According to the product packaging, the product originates from Indonesia and is manufactured by:

PJ. AIR MADU

MAGELANG - INDONESIA

POM TR. NO. 053348358

Side effects

Side effects associated with piroxicam include changes in blood pressure, gastrointestinal disorders (with or without bleeding), anemia, kidney failure and reduced clotting ability.

Long-term use of high doses of paracetamol (acetaminophen) may cause serious liver damage.

What you should do

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.

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

Background

Drugs and natural health products that are authorized for sale in Canada will have 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 December 31, 2013, no adverse reactions suspected to be associated with the use of this product have been reported to Health Canada.

Report a health or safety concern

To report a side effect to a health product to Health Canada:

• 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

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