SUBJECT: Recall Of Ranitidine Tablets USP 150mg And 300mg By Glenmark Pharmaceuticals
January 23, 2020,
The National Agency for Food and Drug Administration and Control has been notified by the United States Food and Drug Administration that GLENMARK PHARMACEUTICALS is voluntarily recalling Ranitidine tablets USP 150mg and 300mg due to possible presence of N-nitrosodimethylamine (NDMA) impurity.
Ranitidine is a drug that belongs to the group called Histamine-2 blockers used to decrease the production of stomach acid, which may reduce irritation to the stomach lining and heal ulcers and other gastrointestinal conditions such as Zollinger-Ellison syndrome and Gastroesophageal reflux disease (GERD).
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant typically found in water and foods, including meats, dairy products and vegetables.
The details of the affected products are as follows;
Product Name: Ranitidine Tablets USP 150 mg and 300 mg
Manufacturers name: Glenmark Pharmaceuticals Inc., USA.
Product description: The 150mg products are packaged in bottle packs of 60’s, 100’s and 500’s, whereas, the 300mg products are packaged in bottle packs of 30’s, 100’s and 250’s.
|NDC||Description||Expiration Date Range|
|Ranitidine Tablets, USP 150mg||12/2019 – 5/2022|
|Ranitidine Tablets, USP 300 mg||12/2019 – 6/2022|
Healthcare Providers and patients of the public are also advised to stop the administration and use of the affected products to avoid negative health implications. Healthcare providers and anyone in possession of the affected products should submit them to the nearest NAFDAC office.
Healthcare Providers and patients are advised to report adverse events related to the use on any of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via firstname.lastname@example.org