Lupin Pharmaceuticals Inc., based in Baltimore, recalled close to 10,000 bottles of the drug made by its Indian parent, Lupin Ltd., the U.S. Food and Drug Administration said on its website. The recall was initiated on Jan. 27 but made public by the FDA this week.
"This is a voluntary recall initiated on our own and of no business consequence," a Lupin spokesman in India said without elaborating
The recall is the latest embarrassing incident for Indian pharmaceutical firms that have thrived in the lucrative market for drugs that have gone off patent.
The U.S. FDA has in recent years increased its vigilance of these firms as India became the second-largest supplier of generic drugs in the U.S.
Lupin—the fifth-largest generic drug maker in the U.S. in terms of prescriptions—gets 40% of its net sales from the U.S.
The latest recall is for Lupin's branded drug Suprax, the brand name for cefixime—an antibiotic used to treat bacterial infections of the ear and upper respiratory tract.
The Indian firm, India's fourth-largest generic drug maker by market capitalization, joins its larger peers in trying to become more vigilant in the face of increasing regulatory scrutiny from the U.S.