CLASS I Drug recall · Reported 20 Mar 2019 · FDA Enforcement Report
Levoleucovorin Injection, 250 mg/, (10 mg/mL) Single-Use Vial recalled
Mylan Institutional is recalling Levoleucovorin Injection, 250 mg/, (10 mg/mL) Single-Use Vial, distributed nationwide in the US. The recall was initiated on 1 Feb 2019 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1059-2019
- FDA event ID
- 82210
- Recalling firm
- Mylan Institutional, Rockford, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 1 Feb 2019
- FDA classified
- 26 Mar 2019
- Reported
- 20 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Feb 2019 | Recall initiated by company | |
| 20 Mar 2019 | Published in enforcement report | +47 days |
| 26 Mar 2019 | Classified by FDA | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: particulate matter identified as copper salts
Product as listed by the FDA
Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30
Where it was distributed
Nationwide in the United States
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: particulate matter identified as copper salts
Which lots are affected?
Lot #: APB032, APB033, Exp. April 2019
Where was it sold?
Nationwide in the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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