D-0152-2018 Class I Terminated

Recalled by Fresenius Kabi USA, LLC — Wilson, NC

Recall Details

Product Type
Drugs
Report Date
January 10, 2018
Initiation Date
October 27, 2017
Termination Date
October 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
203136 syringes

Product Description

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 Pattern

Nationwide in the USA

Code Information

Lot: 6400048