Reported Mar 20, 2019 · Terminated

Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan…

Mylan Institutional Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mylan Institutional Inc · 4951 Hiawatha Dr · Rockford, IL · 61103-1287

Is this the product you have?

    • Levoleucovorin Injection
    • 250 mg/25 mL
    • (10 mg/mL)
    • 25 mL Single-Use Vial
    • Rx only
  • Manufactured forMylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India
  • NDC67457-601-30
Lot codes and dates
    • Lot #: APB032
    • APB033
    • Exp. April 2019
Amount recalled
11,964 cartons of 30 vials

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Presence of Particulate Matter: particulate matter identified as copper salts

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 19, 2020 · Data as of Sep 19, 5:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.