Fresenius Kabi USA, LLC recalls Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton…

Recall date

October 27, 2017

Source

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

Recall number

D-0152-2018

FDA classification

Class I

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

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

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

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