Reported Aug 24, 2022 · Terminated

Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron…

Nephron Sc Inc.

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: Nephron Sc Inc · 4500 12th Street Ext · West Columbia, SC · 29172-3025

Is this the product you have?

  • Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
Lot codes and dates
  • Lot#: 023011 Exp 8/31/2022
Amount recalled
5040 vials

Where it was sold

  • Nationwide

Why it was recalled

cGMP Deviations: deviations leading to potential cross-contamination.

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 Sep 24, 2024 · Data as of Sep 19, 5:06 PM UTC

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