Reported Jan 3, 2024 · Terminated

FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10

Cardinal Healthcare

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: CARDINAL HEALTHCARE · 7200 Cardinal Pl W · Dublin, OH · 43017-1094

Is this the product you have?

    • FIRST LANSOPRAZOLE PT 3MG/ML
    • 300ML
    • Rx Only
  • Distributed ByCutisPharma, Inc., Woburn, MA 01801
  • NDC65628-080-10
Lot codes and dates
  • Batch 21025A
Amount recalled
1 unit

This recall covers 42 products

The agency filed one notice per product. You are reading one of them; the other 41 are below.

29 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

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 29, 2024 · Data as of Sep 19, 5:07 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.