FDA recall D-1059-2019

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 U.S.A., Made in India. NDC: 67457-601-30

Reason for recall

Presence of Particulate Matter: particulate matter identified as copper salts

Distribution

Nationwide in the United States

Key facts

Status

Terminated

Initiation date

2019-02-01

Report date

2019-03-20

Termination date

2020-06-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1059-2019