Reported Feb 23, 2022 · Terminated

Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY…

ANI Pharmaceuticals, 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: ANI Pharmaceuticals, Inc. · 210 W Main St · Baudette, MN · 56623-2467

Is this the product you have?

  • Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only
  • Manufactured byULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10
Lot codes and dates
    • Lot #: 19B064A
    • Exp. Date 03/2022
Amount recalled
5,477 bottles

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

cGMP Deviations

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 Oct 25, 2022 · Data as of Sep 19, 5:55 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.