Strides Pharma Ranitidine tablets within acceptable NDMA limits, says USFDA
New Delhi: Drug firm, Strides Pharma recently announced that the USFDA issued a statement1 on November 1, 2019, providing an update with the latest information on Ranitidine. The agency tested numerous ranitidine products on the market over the past few months and released a summary of the results they have to date.
In this statement, USFDA indicated if they or the manufacturers find N-nitrosodimethylamine (NDMA) levels above the acceptable limits(96 nanograms per day or 0.32 ppm), they are now asking companies to recall ranitidine voluntarily.
In the summary of test results2 provided by USFDA, Strides' Ranitidine Tablets 300 mg (Rx) is within the acceptable limits for NDMA of 96 nanograms per day or 0.32 ppm. Several batches of other manufacturers are above this limit requiring a voluntary recall.
The drug firm further added that it intends to provide additional updates in the next coming days, including potential recommencement of product distribution by Strides of Ranitidine Rx based on available test results.