Reported Dec 2, 2020 · Terminated

Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc.…

Heritage Pharmaceuticals 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: Heritage Pharmaceuticals Inc · 1 Tower Center Blvd Ste 1700 · East Brunswick, NJ · 08816-1145

Is this the product you have?

  • Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only
  • Distributed by
    • Heritage Pharmaceuticals Inc. East Brunswick
    • NJ 08816 Made in India
    • NDC 23155-050-01
Lot codes and dates
    • Lot #: 18029979
    • Exp 1/2021
Amount recalled
7176 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A

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 Jan 28, 2022 · Data as of Sep 19, 4:18 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.