US-based Mylan Pharma initiates voluntary recall of Nizatidine Capsules USP: Solara Active Pharma Sciences

| Updated on January 09, 2020 Published on January 09, 2020

Solara Active Pharma Sciences has said it has come to know that US-based Mylan Pharmaceuticals has initiated a voluntary recall of three lots of Nizatidine Capsules USP (150-mg and 300-mg strengths) due to detected trace amounts of impurity N nitrosodimethylamine. Mylan also indicated that the recall is voluntary and it has not received any reports of adverse events related to these batches to date. Solara Active is in the process of collecting corresponding lots of API from Mylan to carry out its internal investigation. The overall sales of this API to the US market comprise less than 0.1 per cent of total revenues, it further said. Shares of Solara Active closed 0.50 per cent higher at ₹422.65 on the BSE.

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Published on January 09, 2020
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