Reported Aug 24, 2022 · Terminated

PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case,…

Nephron Sterile Compounding Center LLC

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 Sterile Compounding Center LLC · 4500 12th Street Ext · West Columbia, SC · 29172-3025

Is this the product you have?

    • PF-0.125% Bupivacaine HCl Injection
    • USP
    • 625 mg/500 mL (1.25 mg/mL)
    • 500 mL bag
    • packaged in 10 x 1 IV Bag per case
    • Rx Only
    • Nephron 503B Outsourcing Facility
    • 4500 12th Street Extension
    • West Columbia
    • SC 29172
    • NDC 69374-970-05
Lot codes and dates
  • Lots
    • BH2003A
    • Exp. 8/19/2022
    • BH2011A
    • Exp. 11/9/2022
Amount recalled
2030 bags

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 11, 2024 · Data as of Sep 19, 8:04 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.