Reported Nov 20, 2019 · Terminated

Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive,…

Novitium Pharma LLC

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

Is this the product you have?

  • Novitium Pharma Ranitidine Capsules 150
  • mg 500 capsules Rx Only Manufactured by
    • Novitium Pharma LLC 70 Lake Drive
    • East Windsor
    • New Jersey 08520 NDC 70954-001-40
Lot codes and dates
  • all lots within expiry.
Amount recalled
2718 bottles

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Presence of NDMA impurity detected in product.

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 Mar 17, 2021 · 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.