PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: January 10, 2018 Initiated: October 27, 2017 #D-0152-2018

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

Details

Recalling Firm
Fresenius Kabi USA, LLC
Units Affected
203136 syringes
Distribution
Nationwide in the USA
Location
Wilson, NC

Frequently Asked Questions

What product 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. Recalled by Fresenius Kabi USA, LLC. Units affected: 203136 syringes.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Drug on January 10, 2018. Severity: Critical. Recall number: D-0152-2018.