Mylan Voluntarily Recalls Nationwide Three Lots of Nizatidine Capsules USP Due to Trace Amounts of NDMA (N-Nitrosodimethylamine)
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Shots:
- The voluntarily nationwide consumer level recall involves three lots of Nizatidine Capsules (including the 150mg and 300mg strengths) due to trace amounts of NDMA contained in API Nizatidine, USP, manufactured by Mylan Pharmaceuticals Inc
- The recall is for the lots distributed between Jun, 2017 to Aug, 2018. Additionally, the recall is being conducted under the knowledge of the US FDA and the AEs will be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax on www.fda.gov/medwatch/report.htm link
- Nizatidine is targeted short-term treatment (up to 8 wks.) for active duodenal ulcers and active benign gastric ulcers, as maintenance therapy for duodenal ulcer patients for up to one year, and for up to 12 wks. for the treatment of endoscopically diagnosed esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD)
Click here to read full press release/ article | Ref: Mylan | Image: Behance