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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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