FDA recall D-0152-2018

Product

Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20

Reason for recall

Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-10-27

Report date

2018-01-10

Termination date

2020-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilson, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0152-2018