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Recall Observatory FDA recall evidence

Drug 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

D-0152-2018

October 27, 2017

Class I

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 78396
Status
Terminated
Classification
Class I
Quantity
203136 syringes
Official record key
drug-enforcement:D-0152-2018

Official wording

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

Code information: Lot: 6400048

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label MIX-UP