Strides Pharma Science announced that the USFDA issued a statement on 01 November 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 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 results provided by the USFDA, Strides' Ranitidine Tablets 300 mg lots tested by USFDA are within the acceptable NDMA limits of 96 nanograms per day or 0.32 ppm. Several batches of other manufacturers are above this limit requiring a voluntary recall.
The Company 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.
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