Sciegen Metformin product – not part of Recall<br><br>
Sciegen Pharmaceuticals Inc states that the Immediate release tablets Metformin Hydrochloride Tablets, USP 500 mg, 850 mg & 1000 mg manufactured by Sciegen Pharmaceuticals Inc are not part of recall regarding Metformin products.<br><br>
Sciegen Metformin IR tablets complying to FDA requirements of NDMA content less 96 nanograms (0.0376 ppm).<br><br>
Several batches manufactured by Sciegen are tested with a validated test method and the levels are found to ‘below detectable limit’.<br><br>
This data has been submitted to FDA.
It should also be noted that FDA has stated in its press release on May 28th ‘The FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate;
FDA testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin).’ <br><br>
<a>https://www.fda.gov/news-events/press-announcements/fda-alerts-patients-and-health-care-professionals-nitrosamine-impurity-findings-certain-metformin</a>
