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Methotrexate Sodium Injection 25 mg/mL (2mL) – Recall Due to Possible Presence of Cracked Vials - For Health Professionals
- Starting date:
- December 18, 2013
- Posting date:
- December 18, 2013
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- Healthcare Professionals
- Identification number:
- RA-37315
This is duplicated text of a letter from Teva Canada Limited. Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on METHOTREXATE SODIUM INJECTION 25 mg/mL (2mL) - DIN 02099705 - Lots 12J30KK, 12J30KH, 12J30KB
December 18, 2013
Dear Health Care Professional;
Subject:Recall of Methotrexate Sodium Injection 25 mg/mL (2mL) DIN 02099705 – Distributed by Teva Canada Limited (formerly Novopharm Limited) Lots 12J30KK, 12J30KH, 12J30KB due to possible presence of cracked vials
Teva Canada Limited, in consultation with Health Canada, is initiating a voluntary recall to the patient level for 3 lots (listed above) of Methotrexate Sodium Injection 25 mg/mL (2 mL) DIN 02099705, due to the possible presence of some cracked vials in these lots. Sterility of the contents of cracked vials could be compromised.
Teva Canada Limited has received two reports of vial breakage upon removal of the Product’s flip-off cap. As the Product is packaged in glass vials, the potential exists that some vials of the Product may be cracked at the neck of the vial.
Methotrexate Sodium Injection is a medication used in the treatment of neoplastic disease and may also be used as a disease modifying antirheumatic drug (DMARD). The Product may be administered by the intravenous, intramuscular, intra-arterial or intrathecal routes.
Although this Product is used in the hospital and/or oncology clinic setting, Health Canada has advised that there may be instances where it could be used by physicians in their office or by a patient in their home.
- There is a possibility of the presence of some cracked vials in 3 lots of Methotrexate Sodium Injection 25 mg/mL (2 mL). Sterility of the contents of the cracked vials could be compromised.
- Healthcare Professionals should be vigilant of any unusual, or infection related patient symptoms.
- Please examine your inventory and determine if you have any remaining stock of the above mentioned lots of the Product. Stop distributing and quarantine the above mentioned lots of the Product. If you distributed the Products to another practitioner or other supply chain participant, please notify them to cease distribution
- Please review your records and determine if you have provided the above mentioned Products to any of your patients. If you provided Product to a patient, please advise them of the recall and recover any remaining units for return. It is important that you replace the returned vials of Product to ensure completion of their therapy within the prescribed time period. If necessary, please contact Teva Canada Customer Care regarding additional supply of this Product for your patient. (See contact information below.)
- Please return all Products to your point of purchase
No other lots of the Product are affected by this recall.
If you have any specific questions regarding the recall process, please contact Teva Canada Customer Care at 1-800-268-4129.
Managing marketed health product-related adverse reactions depends on Health Care Professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving Methotrexate Sodium Injection 25 mg/mL (2mL) from Lots 12J30KK, 12J30KH, 12J30KB should be reported to Teva Canada Limited or Health Canada.
Teva Canada Limited
30 Novopharm Court
Toronto ,Ontario
M1B 2K9
1-800-268-4129
To correct your mailing address or fax number, contact Teva Canada Limited.
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 (HPFBI)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636
Teva Canada would like to thank you for your understanding and continued support.
Sincerely,
original signed by
Paul Stojanovski
Vice President, Quality and Compliance
Teva Canada Limited