Reported Mar 25, 2020 · Terminated

PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977,…

Par Pharmaceutical 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: Par Pharmaceutical Inc. · 1 Ram Ridge Rd · Chestnut Ridge, NY · 10977-6714

Is this the product you have?

  • PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only
  • Distributed by
    • Par Pharmaceutical Chestnut Ridge
    • NY 10977
    • NDC 0603-5337-31
Lot codes and dates
    • Lot #: 8672518
    • Exp 12/21
Amount recalled
13008 bottles

Where it was sold

  • Nationwide

Why it was recalled

Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg

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

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 9, 2021 · Data as of Sep 19, 7:18 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.