Reported Jan 15, 2020 · Ongoing
Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 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 100 Tablets Manufactured byGlenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513
- India Manufactured forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
- Lot codes and dates
144 of 144 codes
7701030A7701031A7701062A7701063A7701110A7701111A7701112A7701185A7701186A7701187A7701188A7701189A7701269A7701270A7701278A7701279A7701386A7701400A7701401A7701406A7701421A7701434A7701435A7701436A7701452A7701453A7701521A7701522B7701553A7701554A7701555A7701556A7701582A7701817A7701828A7701829A7702001A7702002A7702003A7702012A7702026A7702027A7702064A7702140A7702253A7702254A7702285A7702286A7702287A7702288A7702294A7702413A7702462A7702491A7702492A7702504A7702505A7702515A7702698A7702699A
- Amount recalled
- 1,309,536 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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