Homegrown drug maker
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”, the US health regulator noted in the report.
Lupin initiated the nationwide recall on November 19 this year, it added.
The USFDA has classified both the recalls as class III.
As per the US health regulator, a class III recall is initiated in a “situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”.
Last month, the USFDA had stated that the Mumbai-based drug maker is recalling 16,272 bottles of Gatifloxacin Ophthalmic solution, an antibiotic used to treat bacterial infections of the eyes, in the US market.
As per the US health regulator, the company’s US-based unit is recalling the affected lot due to “failed stability specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration”.
The affected lot was also manufactured at the company’s Pithampur-based plant.
The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.