Lupin is recalling 4,113 cartons of generic oral contraceptive tablets in the US, the world’s largest market for medicines, due to manufacturing issues.
As per the latest enforcement report issued by the US Food and Drug Administration (USFDA), Lupin’s US-based unit is recalling 4,113 cartons of Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg).
The affected lot has been produced at the company’s Pithampur-based manufacturing facility in Madhya Pradesh and distributed in the US by Baltimore-based Lupin Pharmaceuticals, Inc. The company is recalling the lot due to it being Subpotent Drug.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.