Jamp Pharma Corp Recalls Jamp-Methotrexate (USP 50mg/2mL) Due To Particulate Matter

Starting date:

March 13, 2015

Posting date:

March 13, 2015

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product withdrawal

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-52541

• Issue
• Products affected
• What you should do
• Who is affected
• Background
• Report health or safety concerns
• Related AWRs
• Media enquiries
• Public enquiries
• What Health Canada is doing

Issue

Jamp Pharma Corporation, in consultation with Health Canada, is voluntarily recalling one lot of Jamp-Methotrexate USP 50mg/2mL due to the potential presence of foreign particulate matter.

Methotrexate Injection is administered by health care professionals but Health Canada is also aware that this product may be self-administered by subcutaneous injection (under the skin) by patients at home.  The risks associated with subcutaneous injection of foreign particulate matter include local reaction at the injection site and/or swelling or possible allergic reaction and infection.

Products affected

Jamp-Methotrexate USP 50mg/2mLby Jamp Pharma Corporation (lot: 7801372), DIN 02419173

What you should do

• Speak to your healthcare practitioner if you have concerns about your health.
• Consult with your healthcare practitioner about stopping the use of this product and getting a replacement medication in order to complete your scheduled therapy.
• Report any adverse events to Health Canada.

Who is affected

Consumers who have this product for injection by a healthcare professional or for self-administration at home.

Background

Jamp Pharma Corporation also imported from Onco Therapies in India. Health Canada will continue to assess further impact of products supplied by Onco Therapies Ltd. to the Canadian market.

Report health or safety concerns

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

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Related AWRs

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866 225-0709

What Health Canada is doing

Health Canada is monitoring the recall by Jamp Pharma Corporation and should new information about this recall arise, Health Canada will inform Canadians.