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  • Lupin recalls cartons...

Lupin recalls cartons of oral contraceptive drug Tydemy in US

Ruchika SharmaWritten by Ruchika Sharma Published On 13 Dec 2021 6:39 AM  |  Updated On 13 Dec 2021 7:43 AM
Lupin recalls cartons of oral contraceptive drug Tydemy in US
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The company is recalling the lot due to it being "Subpotent Drug", the US health regulator noted in the report.

New Delhi: 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.

Read also: Lupin launches Diagnostics Business in India

lupinlupin newscontraceptive tabletstydemypithampur facilityrecall
Source : PTI
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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