Reported Feb 14, 2018 · Terminated

Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics…

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?

  • Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only
  • Manufactured in India forAuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00
Lot codes and dates
  • Lot # CPO170035
Amount recalled
66,100 vials

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 17, 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.