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  • Lupin, Aurobindo...

Lupin, Aurobindo Pharma unit recall products from US over manufacturing issues

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 24 Jun 2024 9:45 AM  |  Updated On 24 Jun 2024 9:45 AM
Lupin recalls over 2000 bottles of antidepressant medication in US
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New Delhi: According to the US health regulator, Lupin and a unit of Aurobindo Pharma are recalling products from the American market over manufacturing issues.

Specifically, a US-based Lupin unit Lupin Pharmaceuticals Inc is recalling 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) used to treat bacterial infections.

The Company is recalling the medication due to "failed content uniformity specifications".

The affected lot has been produced at the company's Mandideep-based manufacturing plant in Madhya Pradesh.

The company commenced the Class II nationwide (US) recall on May 30 this year.

According to PTI, the US health regulator stated that New Jersey-based Eugia US LLC, a subsidiary of Aurobindo Pharma, is recalling 70,125 vials of Dexamethasone Sodium Phosphate injection USP.

The company is recalling the affected lot due to "failed impurities/degradation specifications", USFDA said.

Eugia commenced the nationwide Class II recall on May 23 this year.

According to USFDA, 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.

Eugia is also recalling 15,500 single-dose vials of Eptifibatide injection from the US market, the American health regulator said.

The medication prevents blood from clotting during episodes of chest pain or a heart attack.

Eugia is recalling the affected lot due to "failed impurities/ degradation specifications", USFDA said.

The company initiated the Class III recall on May 22 this year.

As per USFDA, 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".

India is the largest supplier of generic medicines, with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.

The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, Western Europe, and the US as main destinations.

India has the highest number of USFDA-compliant companies with plants outside the US.

Read also: Lupin collaborates with Fuji Pharma arm for marketing birth control pill Nextstellis in Vietnam, Philippines

lupinlupin newsaurobindo pharmaaurobindo pharma newsUSFDAcefiximeeugiadexamethasone sodium phosphate injectioneptifibatide injectionheart attack
Source : with inputs
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

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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