Reported Feb 8, 2017 · Terminated

MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC…

Fresenius Kabi USA, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930

Is this the product you have?

  • MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Lot codes and dates
    • Lot 6007327
    • exp. 01-2017
    • Lot 6007329
    • exp. 01-2017
Amount recalled
47, 020 vials

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Impurities/Degradation Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 22, 2018 · Data as of Sep 19, 7:52 PM UTC

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