Recall: D-0152-2018

Class I - Dangerous

Class IClassification

2017-10-27Initiated

TerminatedStatus

Fresenius Kabi USA, LLCFirm

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

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.