Mylan Voluntarily Recalls Nationwide Three Lots of Nizatidine Capsules USP Due to Trace Amounts of NDMA (N-Nitrosodimethylamine)
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
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