Solara Active Pharma Sciences announced the company understands from Mylan NVs press release dated 08 January 2020 that Mylan N.V.'s U.S. based Mylan Pharmaceuticals(Mylan) has initiated a voluntary recall of three lots of Nizatidine Capsules, USP (150mg and 300mg strengths) due to detected trace amounts of impurity Nnitrosodimethylamine
(NOMA) contained in the Nizatidine APL Mylan also indicated that the recall is voluntary, and the Company has not received any reports of adverse events related to these batches to date.
The company is in the process of collecting corresponding lots of API from Mylan to carry out its own internal investigation.
The company's last supplies of Nizatidine API to Mylan were made in September 2017 and the company's overall sales of this API to the US market are less than 0.1 % of total company revenues.
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