Reported Feb 17, 2021 · Terminated

Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc.…

Sun Pharmaceutical Industries Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620

Is this the product you have?

  • Pantoprazole Sodium for Injection 40mg/vial For I.V
  • infusion only Distributed bySun Pharmaceutical Industries, Inc. Cranbury
  • NJ 08512 Manufactured bySun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40
Lot codes and dates
    • JKU3595A
    • JKU3596A
    • JKU3597A
    • and JKU3629A
    • Exp 02/2021
Amount recalled
20,475 vials

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurity/Degradation Specifications

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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.

Free recall alerts

Get alerted about new Sun Pharmaceutical Industries Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 3, 2021 · Data as of Sep 19, 6:39 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.