Reported Jan 15, 2020 · Ongoing

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd.…

Glenmark Pharmaceuticals Inc., USA

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: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009

Is this the product you have?

  • Glenmark Ranitidine Tablets USP 300
  • mg Rx Only 30 Tablets Manufactured byGlenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513
  • India Manufactured forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
Lot codes and dates
  • 7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490
Amount recalled
98,988 bottles

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

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

Data as of Sep 19, 4:58 PM UTC

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