Reported Feb 16, 2022 · Terminated

Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, 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?

  • Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only
  • Distributed byAuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10
Lot codes and dates
    • Lot CPB200013
    • exp 9/2022
Amount recalled
35,520 vials

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

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 Aug 20, 2024 · Data as of Sep 19, 6:37 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.