Reported Mar 7, 2018 · Terminated

Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only,…

AuroMedics Pharma LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: AuroMedics Pharma LLC · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401

Is this the product you have?

    • Levofloxacin in 5% Dextrose Injection
    • 250 mg/50 mL (5 mg/mL)
    • 50 mL Single-Use flexible container
    • Rx Only
  • Manufactured forAuroMedics Pharma LLC 6 Wheeling Drive, Dayton
  • NJ 08810 Manufactured for
    • Aurobindo Pharma Limited IDA
    • Pashamylaram - 502307
    • India ---- NDC 55150-243-46
Lot codes and dates
    • Lot CLF160003
    • exp May 2018
Amount recalled
6,072 bags

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Presence of Particulate Matter; contains visible particulate matter identified as mold.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 1, 2020 · Data as of Sep 19, 5:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.