Glenmark Pharmaceuticals Inc, USA initiated a Voluntary Nationwide Recall of Ranitidine medications sold in US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.
Glenmark Pharmaceuticals Inc, USA is only recalling lots of ranitidine-containing products that may contain N-nitrosodimethylamine (NDMA) above the acceptable daily intake levels released by the FDA. Ranitidine Tablets 150 mg and 300 mg is a prescription oral product approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
Consumers who have Ranitidine Tablets, USP subject to this recall should immediately discontinue use and consult with their physician or healthcare provider about treatment options.
Consumers who would like to report any adverse reactions or quality problems experienced as a result of their use of this product, or have questions regarding the use of Ranitidine Tablets, USP can contact Glenmark Drug Safety by phone at Glenmark customer service center at 1-888-721- 7115, Monday thru Friday, 9:00 am – 6:00 pm, US EST, or e-mail at GlobalCustomerService@glenmarkpharma.com. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.
MedImpact Direct Mail® is dedicated to maintaining patient safety. We appreciate your business and will continue to strive to provide you with the best possible service. On every MedImpact Direct Mail® prescription label, there is a description of the drug name with the manufacturer indicated.