Public recall detail

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

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Recall Safety notice
Quick summary

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

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

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

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

Brand

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.

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.
Additional official information
Background{"text":"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."}
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Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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