Jubilant Life Sciences’ arm recalls Pantoprazole Sodium drug from US market

21 May 2013 Evaluate

Jubilant Life Sciences’ US based subsidiary - Jubilant Cadista, has recalled its drug Pantoprazole Sodium (delayed release) from the US market. The drug was manufactured at the company’s India facility at Roorkee and was pulled out for possible deviations from prescribed good manufacturing practices (cGMP). The US Food and Drug Administration (USFDA) has mentioned the reason of recall as cGMP deviations; oral products were not manufactured in accordance with good manufacturing practices.

The recall has been classified as class II, which means use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Jubilant’s nationwide pull-out of affected lots in US is a voluntary recall, initiated by the firm.

The drug Pantoprazole is used for short-term treatment of erosion and ulceration of the esophagus caused by gastroesophageal reflux disease.

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