Lupin, Eugia recall products from US over manufacturing issues: USFDA
Drugmaker Lupin and a unit of Aurobindo Pharma are recalling products from the American market due to manufacturing issues.
Drugmaker Lupin and a unit of Aurobindo Pharma are recalling products from the American market due to manufacturing issues, according to the US health regulator.
As per the latest Enforcement Report issued by the US Food and Drug Administration (USFDA), a US-based unit of Lupin is recalling a medication used to treat bacterial infections.
Baltimore-based Lupin Pharmaceuticals Inc is recalling 3,552 bottles of Cefixime for Oral Suspension (USP 200 mg/5 mL) 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.
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.
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First Published: Jun 23 2024 | 11:58 AM IST