Drug firm Lupin is recalling one batch of Losartan Potassium Tablets, used in treating high blood pressure, from the US market for exceeding permissible impurity level, the US health regulator said.
The US Food and Drug Administration (USFDA) in its enforcement report said Indian firm was recalling a batch of 34,368 bottles as the drug did not meet specification for impurities at the nine-month stability station.
The batch, which is being recalled, was due to expire in July next year, the report said. The company produces the drug at its Goa facility.
The recall falls under the FDA's class II category which means that the use of the drug may cause temporary or medically reversible adverse health consequences, but unlikely to have serious adverse health consequences.
When contacted, Lupin corporate spokesperson said: "We had one batch of Losartan Potassium tablets failing in impurities at one stability time point. As an abundant precaution, we have voluntarily recalled the batch. The recall is limited to one batch. The total value of the batch is insignificant."
Shares of Lupin today closed at Rs 446 on the Bombay Stock Exchange, down 0.42% from previous close.
