Lupin recall contraceptive drug in US

NEW DELHI: Indian drug maker Lupin Ltd is voluntarily recalling 10,800 pouches of a contraceptive drug in the US after impurities were found during a stability test.

“This product is being recalled due to an out of specification test result for an individual unspecified impurity, identified as Bisphenol-A, during the 3 month long term stability testing,” US Food and Drug Administration ( FDA) said.

The recall of the drug, made at the company’s Indore plant in Madhya Pradesh, is ongoing, FDA said.

The recall is unlikely to cause any material financial impact on the Mumbai-based company. Since the recall falls under the FDA’s Class III category, the use of the drug is not likely to have any adverse effects on the health of patients. Such recalls are common in the US and does not necessarily mean that there is a problem with the quality of the medicine.

Lupin’s share price closed at Rs 537.50, down 1.35% at the Bombay Stock Exchange on Tuesday.