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Methotrexate Injection USP 50 mg/2 mL - Voluntary Recall Due to the Potential Presence of Foreign Particulate Matter

Starting date:
March 12, 2015
Posting date:
March 12, 2015
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals, General Public
Identification number:
RA-52513

   

This is duplicated text of a letter from Mylan Pharmaceuticals ULC prepared in collaboration with Health Canada.

Audience

Clinics, Pharmacies and Hospital Pharmacies who might have received and/or dispensed this product. Please distribute to health care professionals who might administer this product to patients (oncologists, rheumatologists, homecare programs or clinics).

Key messages

  • Mylan Pharmaceuticals ULC, in consultation with Health Canada, is initiating a voluntary recall for one (1) lot of Methotrexate Injection USP 50 mg/2 mL (lot 7801370), due to the potential presence of foreign particulate matter.
  • In addition, investigations related to controls for manufacturing sterile products at the manufacturing site are ongoing.
  • Inadvertent injection of foreign particulate matter could result in risks to patient health.
  • Vials of the affected lot should not be used and should be returned as outlined in the Recall Notice issued by Mylan on March 10, 2015. Health care professionals are advised to remain vigilant in their follow up with patients who have used the impacted lot.

                       

Issue

The company has initiated this recall due to the presence of particulate matter observed in one vial from this lot of Methotrexate Injection USP 50 mg/2 mL. Presence of foreign particulate matter in vials of the affected lot could pose the following risks, if injected by intravenous or intra-arterial routes: local inflammation, phlebitis, allergic response and/or embolization in the body.

This is the only lot of Methotrexate that has been distributed by Mylan. No complaints or adverse event reports have been received in relation to this product.

Products affected

The product impacted is:

Product DIN No. Lot No. Exp. Date
Methotrexate Injection USP 50 mg/2 mL 02417626 7801370 Jan. 2016

The lot has been released to distribution on Oct. 24, 2014.

Background information

Methotrexate is indicated in the treatment of cancer, psoriasis and arthritis-related conditions. Mylan has initiated an investigation to further determine the root cause related to this issue and will implement necessary corrective and preventive actions.

Who is affected

Information for consumers

Consumers who have this product in their homes should not use the product and should contact their doctor and return the product to the pharmacy or clinic where the medication was obtained. Please ensure that you get replacement medication in order to complete your scheduled therapy.
 
Consumers should consult with their health care professional if they need more information.

Information for health care professionals

Vials of the affected lot should not be used and should be returned as outlined in the Recall Notice issued by Mylan on March 10, 2015.

Please inform patients and health care professionals in your organization of this recall notification. Health care professionals should also notify affiliated staff administering this product in a home care setting.

If your institution or pharmacy has distributed this product further, notify your consignees that they may have received the product lot identified above and ask them to return the product as indicated in the Recall Notice.

Action taken by Health Canada

Health Canada is communicating this important safety information to health care professionals and to the public through its MedEffect Canada website. Health Canada has also communicated this recall and related information in a Public Advisory. Health Canada is also monitoring the recall and the implementation of necessary corrective and preventive actions.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious local inflammation, phlebitis, allergic response and/or embolization in the body or other serious or unexpected infection or unexpected side effects in patients receiving Methotrexate Injection 50 mg/2mL should be reported to Mylan Pharmaceuticals ULC or Health Canada.

Mylan Pharmaceuticals ULC
85 advance Road
Etobicoke, ON M8Z 2S6
1-800-575-1379

To correct your mailing address or fax number, contact Mylan Pharmaceuticals ULC.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

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

For other health product inquiries related to this communication, contact Health Canada at:
Health Products and Food Branch Inspectorate
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-237-9675
Fax: 1-613-946-5636

Original signed by

Anca Schmidt
Senior Director, Quality
Mylan Pharmaceuticals ULC


For more information

The manufacturer advised Health Canada of the risk associated with this health product, and has recalled the impacted product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.