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Mylan Recalls Methotrexate Injection (USP 50mg/2mL) Due To Particulate Matter

Starting date:
March 11, 2015
Posting date:
March 11, 2015
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product withdrawal
Audience:
Healthcare Professionals, Hospitals, General Public
Identification number:
RA-52515

Issue

Mylan Pharmaceuticals ULC, in consultation with Health Canada, is voluntarily recalling one lot of Methotrexate Injection USP 50 mg/2 mL due to the potential presence of foreign particulate matter. At this time, no other lots of this product have been distributed by Mylan.

Methotrexate Injection is administered by healthcare 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

  • Methotrexate Injection USP 50 mg/2 mL by Mylan Pharmaceuticals ULC (lot 7801370), DIN 02417626

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

Mylan Pharmaceuticals ULC notified Health Canada of a potential manufacturing issue identified during an inspection of Onco Therapies, one of its suppliers in India, by a regulatory partner. Mylan’s internal investigation identified the presence of particulate matter in one sample of Methotrexate Injection USP 50 mg/2 mL. Health Canada is currently assessing 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.

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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 and the implementation of necessary corrective and preventive actions. Should new information about this recall arise, Health Canada will inform Canadians.