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  • Lupin recalls birth...

Lupin recalls birth control pill Mibelas 24 Fe in US over failed impurities specification

Ruchika SharmaWritten by Ruchika Sharma Published On 2020-08-22T13:00:19+05:30  |  Updated On 22 Nov 2022 5:25 PM IST
Lupin recalls birth control pill Mibelas 24 Fe in US over failed impurities specification
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The reason for the recall is" failed impurities/degradation specifications: Out of specification result observed in related substance test", the USFDA said.

New Delhi: Drug major Lupin is recalling 5,60,922 pouches of a birth control product in the US, as per the US Food and Drug Administration (USFDA).

Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.

The product is used to prevent pregnancy. It is manufactured in India and then supplied in the US market by Lupin Pharmaceuticals Inc, the report said.
One pouch of Mibelas 24 Fe contains 28 chewable tablets.
The reason for the recall is "failed impurities/degradation specifications: Out of specification result observed in related substance test", the USFDA said.
The nationwide (US) recall was initiated by the company on July 21 this year and the USFDA classified it as a Class II recall.
As per the US health regulator, a class II recall is initiated in a "situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The company did not elaborate if the product is also sold in India. A mail sent to the company in this regard remained unanswered.
Usually, drug firms cater to the domestic market from separate manufacturing plants. The USFDA approved facilities are specifically utilised to cater to the US, the largest market for pharmaceutical products in the world.
Read also: Lupin Presents Phase 3 Data For Solosec In Female Trichomoniasis Patients

lupinlupin newsbirth control pillsusfdamibelas 24 fenorethindrone acetateethinyl estradiol tabletsferrous fumarate tabletsrecall
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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