Glenmark Pharmaceuticals Recalls Ranitidine Tablets

Glenmark Pharmaceuticals is recalling unexpired lots of Ranitidine Tablets due to potential presence of N-nitrosodimethylamine (NDMA).

Glenmark Pharmaceuticals Inc., USA announced on Dec. 17, 2019 that it is recalling all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg because of the potential presence of N-nitrosodimethylamine (NDMA) levels above the FDA-acceptable daily intake levels, based on FDA-validated tests. NDMA is an environmental contaminant that is classified as a probable human carcinogen.

The company manufacturers Ranitidine at two approved manufacturing facilities: 16 of the 928 recalled lots were manufactured by Glenmark Pharmaceuticals Ltd., Goa, India and 912 lots were manufactured by Strides Pharma Science Limited, Puducherry, India. The recalled lots, which were distributed directly to wholesalers, distributors, retailers, and repackagers nationwide are identified as follows:

  • Ranitidine Tablets, USP 150mg; NDC numbers 684620-248-60, 684620-248-01, and 684620-248-05; expiration 12/2019–5/2022

  • Ranitidine Tablets, USP 300 mg; NDC numbers 684620-249-30, 684620-249-01, and, 684620-249-20; expiration 12/2019–6/2022

Ranitidine is a histamine-2 blocker used to treat and prevent ulcers and treat gastroesophageal reflux disease. As of December 17, the company has not received any reports of adverse events related to the recall. Adverse events may be reported to FDA through its MedWatch program.

Source: FDA