Lupin recalls 4,113 cartons of oral contraceptive medicine in US market
Homegrown drug maker 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, 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.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Dear Reader,
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.
Digital Editor