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

Recall date

February 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1059-2019

FDA classification

Class I

Brand / firm

Mylan Institutional Inc

Sold / distributed

Nationwide in the United States

Why it was recalled

Presence of Particulate Matter: particulate matter identified as copper salts

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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