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

Starting date:
March 14, 2015
Posting date:
March 14, 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-52539

   

This is duplicated text of a letter from the Jamp Pharma Corporation prepared in collaboration with Health Canada.

Audience

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

Key messages

  • Jamp Pharma Corporation in consultation with Health Canada is initiating a voluntary recall for one (1) lot of Jamp-Methotrexate Injection USP 50 mg/2 mL (lot # 7801372), due to the potential presence of foreign particulate matter.
  • 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 Jamp on March 13, 2015. Health care professionals are advised to remain vigilant in their follow up with patients who have used the impacted lot.

                           

Issue

Jamp Pharma Corporation, in consultation with Health Canada, has voluntarily initiated a recall due to the potential presence of particulate matter in one (1) lot of Jamp-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: local inflammation, phlebitis, allergic response, infection and/or embolization in the body.

No complaints or adverse event reports have been received in relation to this product.

Investigations related to controls for manufacturing sterile products at the manufacturing site are ongoing.

Products affected

The product impacted is:

Product DIN No. Lot No. Exp. Date
Jamp-Methotrexate Injection USP 50 mg/ 2 mL 02419173 7801372 JA 2016

This lot has been released to distribution on October 27th 2014.

Background information

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

Who is affected

Information for consumers

Consumers who have this product in their homes should not use the product and should return the product to the pharmacy or medical 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 or have concerns about their health.

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 Jamp on March 13, 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 Jamp-Methotrexate Injection 50 mg/2 mL should be reported to Jamp Pharma or to Health Canada.

Jamp Pharma Corporation
1380 – 203, Newton
Boucherville, Qc
J4B 5H2
1-866-399-9091
Customer service: serviceclient@jamppharma.com
Adverse reaction : pv@jamppharma.com

To correct your mailing address or fax number, contact Jamp Pharma Corporation.

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

Stéphane Quirion
Quality Assurance Director


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.