Reported Apr 24, 2024 · Terminated

Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake…

Novitium Pharma LLC

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: Novitium Pharma LLC · 70 Lake Dr · East Windsor, NJ · 08520-5321

Is this the product you have?

  • Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only
  • Manufactured by
    • Novitium Pharma LLC
    • 70 Lake Drive
    • East Windsor
    • New Jersey 08520
    • NDC 70954-200-10
Lot codes and dates
    • Lot M23011A
    • Exp. 12/2024
Amount recalled
1,003 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications

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 Jul 16, 2024 · Data as of Sep 19, 5:06 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.