FDAClass IMarch 20, 2019

Levoleucovorin Injection recall: Particulate Matter

Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103…

Why was Levoleucovorin Injection recalled?

Presence of Particulate Matter: particulate matter identified as copper salts

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: APB032, APB033, Exp. April 2019

Product
Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103…
Recalling firm
Mylan Institutional Inc
Quantity
11,964 cartons of 30 vials
Distribution
Nationwide in the United States
Recall date
March 20, 2019
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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